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AyuFlex: Does AyuFlex Work?

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The Effect of AyuFlex® Supplementation on Joint Health

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Condition or disease Intervention/treatment Phase
Arthralgia Dietary Supplement: AyuFlex Dietary Supplement: Placebo Not Applicable

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Layout table for study information

Study Type : Interventional (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of AyuFlex® Dietary Supplementation on Joint Mobility, Comfort and Functional Capacity in Healthy Overweight Subjects
Study Start Date : November 2015
Actual Primary Completion Date : February 7, 2017
Actual Study Completion Date : February 7, 2017

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  1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Change in score from Day 0 to day 14, 42, and 84 ]
  2. Visual Analogue Scale scores for discomfort, mobility, disability [ Time Frame: Change in score from Day 0 to day 14, 42, and 84 ]
    Inflammatory biomarkers [ Time Frame: Change from Day 0 to 84 ]

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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study: 35 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
  • Healthy male or female volunteers >35 to <70 years of age.
  • Non-smoker.
  • Body Mass Index (BMI) greater than 30 kg/m2 and less than 45 kg/m2 at screening.
  • Willing to maintain current background dietary and physical activity pattern throughout study period.
  • No knee joint discomfort at rest.
  • Experience knee joint discomfort with activity or exercise within the last 2 weeks of at least 30 mm out of 100mm on VAS rating for "knee discomfort with activity or exercise at any time over the last 3 weeks".
  • Must achieve a rating of at least 30mm on a 100mm VAS at any point throughout the standardized lower extremity exercise performance screening test (Screening test = 3 sets of 10-12 repetitions on seated knee extension machine + 3-minute walk test at maximal walking velocity).

Females of childbearing potential must agree to use one of the following acceptable birth control methods:

  1. Surgically sterile (hysterectomy or bilateral oophorectomy);
  2. Surgically sterile (bilateral tubal ligation with surgery at least 6 weeks prior to study initiation);
  3. Intrauterine device (IUD) in place for at least 3 months;
  4. Abstinence (not having sexual intercourse);
  5. Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening and through study completion;
  6. Vasectomized partner.
  • Subjects with an established diagnosis of inflammatory joint disorder or osteoarthritis per ACR (American College of Rheumatology) guidelines.
  • Currently taking, or chronic use within 30 days of anti-inflammatory supplements, Boswellia, Curcumin, Omega-3 fatty acids, Glucosamine, Chondroitin, MSM, or Collagen supplements of any type.
  • Daily use of NSAIDs (non-steroidal anti-inflammatory drugs); however, daily use of 81 mg of aspirin (not > 81 mg) for cardioprotection is allowed.
  • Upon physical screening by the medical staff, any subject with signs of overt nutrient deficiencies or metabolic abnormalities such as anemia. This will also need to be included in the screening assessment.
  • Subjects with a history of knee or hip joint replacement surgery, or any hip or back pain which interferes with walking or exercise testing utilized throughout the study.
  • Glucocorticoid (Corticosteroid) injection, hyaluronic acid injection, prolotherapy, or PRP (platelet rich plasma) injection, bone marrow or other regenerative injection in affected knee within 6 months prior to enrollment in study.
  • Individual has any recent illness or condition (within 6 months of screening) that the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, or might confound the interpretation of the study results or put the person at undue risk.
  • Known or suspected pregnancy, planned pregnancy, or lactation.
  • If the subjects has been treated for any psychiatric illness or hospitalized for such within the past year, upon PI discretion, will be excluded from the study.
  • History of allergic reaction or known sensitivity to Terminalia chebula or other chemically related botanical/ herbal products or supplements.
  • Any food allergy, intolerance, restriction or special diet that, in the opinion of the Investigator, could contraindicate the subject’s participation in this study.
  • Vital sign abnormalities (seated, resting systolic blood pressure lower than 90 or higher than 150 mmHg, diastolic blood pressure lower than 50 or higher than 100 mmHg, or heart rate less than 50 or more than 110 bpm) at screening.
  • History or clinically significant gastrointestinal disorder, (eg, inflammatory bowel diseases), presence of any gastrointestinal pathology, persistent gastrointestinal symptoms (eg, diarrhea, vomiting), liver or kidney disease, gastric bypass, gastric stapling, use of Lapband, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of dietary supplements.
  • History of active neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic/ autoimmune, psychiatric, or metabolic disease that is considered clinically significant by the PI.
  • Recent history of (within past 12 months), or strong potential for, alcohol or substance abuse. Alcohol abuse will be defined as >14 drinks per week (1 drink = 12 oz beer, 5.0 oz wine, or 1.5 oz distilled spirits).
  • Exposure to any investigational agent or drug product within 30 days prior to study entry.
  • Subjects who have any physical disability which could interfere with their ability to perform the functional performance measures included in this protocol.
  • Individual has a condition the Investigator believes would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results or put the patient at undue risk.

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

To be a safer and allergy-free alternative to chondroitin and glucosamine supplements, the brand says it is devoid of potentially harmful ingredients like as flavoring, coloring, and preservatives, as well as vegetarian and vegan-friendly.

What Company Produces AyuFlex?

AyuFlex is formulated and manufactured by Natreon Inc., headquartered in New Jersey with an R&D facility in Kolkata, India. The company deals in Ayurvedic products, based on traditional Indian medicine science.

They claim to develop products containing tested Ayurvedic ingredients, which are backed with adequate scientific research and result in improvement of health and overall well-being. Their product line includes supplements, food & beverages, personal care, and medical foods.

AyuFlex-Reviews

AyuFlex Review – Images from a Health Web Magazine

The brand also claims that aside from its beneficial effects on the joints, the overall health also improves without the side effects sometimes associated with certain joint formulations.

Who Is The Manufacturer Of AyuFlex?

AyuFlex is formulated and manufactured by Natreon Inc., headquartered in New Jersey with an R&D facility in Kolkata, India. The company deals in Ayurvedic products, based on traditional Indian medicine science.

They claim to develop products containing tested Ayurvedic ingredients, which are backed with adequate scientific research and result in improvement of health and overall well-being. Their product line includes supplements, food & beverages, personal care, and medical foods.

AyuFlex

AyuFlex Review – Health Web Magazine Images

Natreon's AyuFlex, a clinically studied and standardized aqueous extract of Terminalia chebula, significantly improves joint discomfort according to a human clinical study just published in The Asian Journal of Pharmaceutical and Clinical Research. AyuFlex is a GRAS-affirmed and patented ingredient for joint health and pain relief.

Study Demonstrates Benefits of Natreon’s AyuFlex for Joint Health

Study found AyuFlex could significantly improve joint discomfort.

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Natreon's AyuFlex, a clinically studied and standardized aqueous extract of Terminalia chebula, significantly improves joint discomfort according to a human clinical study just published in The Asian Journal of Pharmaceutical and Clinical Research. AyuFlex is a GRAS-affirmed and patented ingredient for joint health and pain relief.

Osteoarthritis (OA) is one of the most common forms of arthritis and is the leading cause of disability in American adults. It is a chronic condition that is known to affect weight-bearing and other moveable joints. In the U.S., an estimated 27 million people older than 25 years have clinical OA. Traditionally, NSAIDs have been the mainstay of treatment for acute and chronic pain conditions, including osteoarthritis. However, the risks of gastrointestinal toxicity and renal impairment have led to the search for alternative analgesics with fewer adverse effects, such as Terminalia chebula.

In this randomized, double-blind, placebo controlled study, a total of 100 healthy human volunteers suffering from joint discomfort for at least 6 months were randomized into five treatment groups: AyuFlex 500 mg twice daily, AyuFlex 500 mg twice daily + Proprietary Chromium Complex (PCC) 400 μg once daily, PCC 400 μg once daily alone, placebo, and AyuFlex 250 mg twice daily for 12 weeks. Proprietary Chromium Complex (PCC) was added to the study because in a previous clinical study at Murray State University in Kentucky, this compound significantly improved joint discomfort in dogs, and its efficacy in humans needed to be evaluated. Assessment of symptoms of knee joint pain and discomfort was done by modified Western Ontario and McMaster Universities Arthritis Index (mWOMAC) and knee swelling index (KSI). Visual analog scale (VAS) was also used for subjective assessment of pain, stiffness, and disability.

Results from this study showed that treatment with AyuFlex 500 mg twice daily for 12 weeks resulted in significant improvements in mWOMAC scores compared to placebo (36% reduction vs. 4.52% in placebo; p < 0.001), knee swelling index ( p < 0.001 vs. placebo), and VAS pain, stiffness, and disability (p < 0.001 for all categories vs. placebo). The therapeutic benefit was evident in as little as 4 weeks. In addition, the number of rescue medications (acetaminophen) used by subjects was the least in the AyuFlex 500 mg twice daily group. This supports the analgesic efficacy of AyuFlex. The response seems to have a linear relationship with dose. In regards to safety, all the study medications were well tolerated and no serious adverse events were reported. No subjects dropped out of the study and all laboratory parameters were within normal limits at the end of the study. Due to its positive safety profile and ability to improve joint discomfort, Natreon suggested AyuFlex might be a good choice for acute or chronic painful ailments, especially in patients who may be at higher risk for gastrointestinal or renal complications.

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Ayuflex reviews

Lopez et al. BMC Complementary and Alternative Medicine (2017) 17:475 DOI 10.1186/s12906-017-1977-8

Effects of dietary supplementation with a standardized aqueous extract of Terminalia chebula fruit (AyuFlex®) on joint mobility, comfort, and functional capacity in healthy overweight subjects: a randomized placebo-controlled clinical trial H. L. Lopez1*, S. M. Habowski1, J. E. Sandrock1, B. Raub1, A. Kedia1, E. J. Bruno2 and T. N. Ziegenfuss1

Abstract Background: Joint and connective tissue integrity, comfort and function are paramount to optimal performance in exercise, recreational and occupational activities. The fruit of Terminalia chebula has been used extensively in various traditional health systems for different ailments, with additional preclinical and clinical data demonstrating antioxidant and anti-inflammatory potential. The aim of this study was to evaluate the effects of a standardized aqueous extract of Terminalia chebula fruit (AyuFlex®) dietary supplementation on joint mobility, comfort, and functional capacity in healthy overweight subjects. Methods: One-hundred and five (105) overweight, apparently healthy male and female subjects (35–70 years of age) were pre-screened and randomized to one of three groups for 84 days: placebo, AyuFlex1 (250 mg twice daily) or AyuFlex2 (500 mg twice daily) in a randomized, double-blind, placebo-controlled design. A two-week placebo lead-in period was used to improve data quality/validity. All subjects had no knee joint discomfort at rest, but experienced knee joint discomfort only with activity/exercise of at least 30 on 100 mm Visual Analog Scale (VAS). Primary outcome measures included symptoms of joint health and function as measured by modified-Knee Injury & Osteoarthritis Outcomes Score (mKOOS) global & modified-Western Ontario and McMaster Universities Arthritis Index (mWOMAC) subscales (discomfort, stiffness and function). Secondary outcomes included VAS questionnaires on overall/whole-body joint health, low back health, knee mobility, willingness and ability to exercise, 6-min walk test for distance and range of motion (ROM) of pain-free knee flexion/extension. Tertiary outcome measures included inflammatory (high sensitivity C-reactive protein (hsCRP), tumor necrosis factor (TNF)-α) and extracellular matrix (ECM)/Connective Tissue (COMP) biomarkers, and safety (vital signs and blood markers) & tolerability (Adverse Event (AE)/ side effect profiles). (Continued on next page)

* Correspondence: [email protected] 1 Division of Sports Nutrition and Exercise Science, The Center for Applied Health Sciences, 4302 Allen Road, Suite 120, Stow, OH 44224, USA Full list of author information is available at the end of the article © The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

Lopez et al. BMC Complementary and Alternative Medicine (2017) 17:475

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Results: Compared to placebo, at day 84 AyuFlex® treatment significantly: 1) improved mKOOS global scores in AyuFlex1 + AyuFlex2 (P = 0.023), and improved total and physical function subscale of mWOMAC relative to baseline, 2) improved VAS scores for Knee Discomfort with activity/exercise in AyuFlex1 + AyuFlex2 (P = 0.001) relative to baseline, 3) improved VAS scores for whole-body joint function in AyuFlex1 + AyuFlex2 (P 81 mg) for cardioprotection is allowed. ● Upon physical screening by the medical staff, any subject with signs of overt nutrient deficiencies or metabolic abnormalities such as anemia. This will also need to be included in the screening assessment. ● Glucocorticoid (Corticosteroid) injection, hyaluronic acid injection, prolotherapy, or PRP (platelet rich plasma) injection, bone marrow or other regenerative injection in affected knee within 6 months prior to enrollment in study. ● Individual has any recent illness or condition (within 6 months of screening) that the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, or might confound the interpretation of the study results or put the person at undue risk. ● Known or suspected pregnancy, planned pregnancy, or lactation. ● If the subjects has been treated for any psychiatric illness or hospitalized for such within the past year, upon PI discretion, will be excluded from the study. ● History of allergic reaction or known sensitivity to Terminalia chebula or other chemically related botanical/ herbal products or supplements. ● Any food allergy, intolerance, restriction or special diet that, in the opinion of the Investigator, could contraindicate the subject’s participation in this study. ● Vital sign abnormalities (seated, resting systolic blood pressure lower than 90 or higher than 150 mmHg, diastolic blood pressure lower than 50 or higher than 100 mmHg, or heart rate less than 50 or more than 110 bpm) at screening. ● History or clinically significant gastrointestinal disorder, (eg, inflammatory bowel diseases), presence of any gastrointestinal pathology, persistent gastrointestinal symptoms (eg, diarrhea, vomiting), liver or kidney disease, gastric bypass, gastric stapling, use of Lapband, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of dietary supplements. ● History of active neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic/ autoimmune, psychiatric, or metabolic disease that is considered clinically significant by the PI. ● Recent history of (within past 12 months), or strong potential for, alcohol or substance abuse. Alcohol abuse will be defined as >14 drinks per week (1 drink = 12 oz. beer, 5.0 oz. wine, or 1.5 oz. distilled spirits). ● Exposure to any investigational agent or drug product within 30 days prior to study entry. ● Subjects who have any physical disability which could interfere with their ability to perform the functional performance measures included in this protocol. ● Individual has a condition the Investigator believes would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results or put the patient at undue risk.

● Knee joint: ○ No knee joint discomfort at rest. ○ Experience knee joint discomfort with activity or exercise within the last 2 weeks of at least 30 mm out of 100 mm on VAS rating for “knee discomfort with activity or exercise at any time over the last 2 weeks”. ○ Must achieve a rating of at least 30 mm on a 100 mm VAS at any point throughout the standardized lower extremity exercise performance screening test (Screening test = 3 sets of 10–12 repetitions on seated knee extension machine +3-min walk test at maximal walking velocity). ● Females: ● Non-pregnant, non-lactating females who agree to use effective contraceptive methods throughout the course of the study. ● Females of childbearing potential must agree to use one of the following acceptable birth control methods: ○ Surgically sterile (hysterectomy or bilateral oophorectomy); ○ Surgically sterile (bilateral tubal ligation with surgery at least 6 weeks prior to study initiation) ○ Intrauterine device (IUD) in place for at least 3 months ○ Abstinence (not having sexual intercourse) ○ Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening and through study completion

BID. Subjects were given enough test product to consume 1 dose twice daily (with breakfast and dinner) until Day 14 and Day 42, respectively. During Visit #4, subjects were given the remainder of their respective test product to finish out the study. HPLC analysis of commercial batch AYF-110315 of the test product AyuFlex®, a standardized aqueous extract of T. chebula fruit (commercial product from Natreon Inc., New Jersey, USA) (AF) was confirmed to contain 58% tannins, with 33.8% chebulinic acid, 9.4% chebulagic acid, 9.4% gallic acid, 3.4% elagic acid, 5.2% total flavonoids, 6.1% sugars as D-glucose and D-fructose. Both AF and Placebo capsules included microcrystalline cellulose, croscarmellose sodium (24 mg), silicon dioxide (6 mg) and magnesium stearate (6 mg) as excipients. Placebo capsules contained microcrystalline cellulose at 400 mg, while AF 250 mg capsules contained 300 mg of microcrystalline cellulose and AF 500 mg capsules contained 109 mg microcrystalline cellulose. Both AF test capsule product and placebo capsules were provided by Natreon, Inc. Compliance to the supplementation protocol was monitored by having subjects complete a daily supplementation

Lopez et al. BMC Complementary and Alternative Medicine (2017) 17:475

Fig. 3 Enrollment and randomization flow chart

(check off) log. In addition, study participants were required to return their supplement containers for pill counts and were reminded of details associated with the study protocols with weekly text messages and/or emails.

Outcome variables Measures of comfort, mobility and function

Determination of self-reported feelings of joint health, comfort, mobility, and function were the primary outcome measures at every study visit, and were assessed with the modified Knee Injury and Osteoarthritis Outcomes Score (mKOOS) global score, modified Western Ontario and McMaster Universities Arthritis Index (mWOMAC) subscale and several 100 mm Visual Analog Scales (VAS) [20, 21]. The global mKOOS test is composed of four categories (Symptoms, Stiffness, Discomfort, and Function/Daily Living Activities); possible scores range from 0 for individuals with maximum discomfort or functional challenges to 100 for no issues with discomfort or mobility whatsoever (higher scores are favorable). Additionally, mWOMAC subscale scores consist of 24 items divided into three subscales assessing discomfort (5 items), stiffness (2 items) and physical function (17 items).

The anchored 100 mm VAS were utilized to acquire psychometric, self-reported data that represented their feelings over that day and the previous week based on two diametric descriptions [22, 23]. Subjects were asked to rate their feelings of: level of discomfort in the right knee with activity/exercise (No Discomfort At All; Most Discomfort Possible), level of discomfort in the left knee with activity/exercise (No Discomfort At All: Most Discomfort Possible); overall knee mobility (No Motion At All: Greatest Motion Possible); overall arm, hip, and leg function (No Function At All: Greatest Function Possible); low back health (Worst Possible: Best Possible); and willingness to exercise (Lowest Possible: Highest Possible). Joint mobility

After obtaining measurements of Comfort, subjects’ voluntary range of motion was measure at both knee joints. Measures of flexion and extension were measured in both standing and supine (laying) positions. Subjects were instructed to bring each knee comfortably through the range of motion that allowed them to move without experiencing pain or discomfort. An Elite Medical Instruments™ 8-in. goniometer was centered at the subjects’ lateral epicondyle of the femur, and then