To assess the effect of dietary supplement capsules compared toPlacebo capsules on joint health

Not Applicable

Conditions: Health Condition 1: M17- Osteoarthritis of knee

Registration Number: CTRI/2020/07/026603

Lead Sponsor: OmniActive Health Technologies

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Male and/or female subjects aged between 35 and 75 years

(both limits inclusive).

2. Clinical diagnosis of unilateral or bilateral knee osteoarthritis

for at least greater than 3 months, as presented by pain in the

knee at least for last 3 months.

3. Subject with index knee joint pain rated >= 60 on a 100-point

Pain-VAS scale.

4. Subject with knee osteoarthritis grade II/III (Kellgren-

Lawrence classification).

5. Subjects willing to be involved in regular physical activity

such as walking, climbing stairs, recording forms, eating,

exercise behaviors, etc.

6. Subjects who are able to walk for at least 6 minutes at a

moderate-to-brisk pace on treadmill.

7. Subjects willing to avoid NSAIDs and other antiinflammatory

medications during the study period.

8. Subjects who agree to stay weight stable during the study

period.

9. Subject able to follow the instruction for Investigational

product administration and is 100% compliant with

Investigational product during placebo run-in period.

10. Female subjects of child bearing potential practicing an

acceptable method of birth control such as Intrauterine Device

in place for at least 3 months prior to the start of the study and

remaining in place during the study period, contraceptive

transdermal, injection or implants, non-hormonal or

hormonal, abstinence: Subjects who shall be practicing

abstinence shall agree to have a documented second

acceptable method of birth control should the subject become

sexually active during the course of her study participation for

the duration of the study as judged by the investigator(s)/study

physician and agree to follow the same should be used during

treatment.

Postmenopausal for at least 1 year.

Surgically sterile (bilateral tubal ligation/bilateral

oophorectomy/hysterectomy has been performed on the

subject).

11. Subjects willing to provide written consent.

12. Subjects shall be willing and able to understand and comply

with the requirements of the study, consume the study IP as

instructed, return for the required treatment period visits,

comply with therapy prohibitions, and be able to complete the

study.

Exclusion Criteria

1. Subjects who are pregnant, nursing, or planning a pregnancy

within the study participation period.

2. Subjects with positive Urine Pregnancy Test at Screening

/Randomization Visit.

3. Subjects with previous history of knee osteoarthritis for more

than 3 years.

4. Subjects with previous history of any knee joint replacement

surgery.

5. Subjects with severe knee osteoarthritis in Grade 4 as per

Kellgren and Lawrence Scale.

6. Subjects unwilling to refrain from the use of NSAIDs

(including low dose aspirin 50 mg/day for cardiovascular

health) or herbal/ nutraceutical supplements for joint health or

local analgesics during the study duration.

7. Subjects with history hypothyroidism and have the thyroid

deficiency except euthyroid.

8. History of allergy or sensitivity to Curcumin, Boswellia and

Ashwagandha, related compounds or any component of the

formulation.

9. Subjects with use of any immunosuppressive drugs in the last

12 months (including steroids).

10. Subjects with poorly controlled hypertension. (Systolic Blood

Pressure >=140 mm Hg and Diastolic Blood Pressure >= 90 mm

Hg).

11. Subjects with history of uncontrolled diabetes.

12. Subjects with history of restless leg syndrome.

13. Subjects with evidence of malignancy.

14. Use of Glucocorticoid injection or hyaluronic acid injection in

the affected joint within 3 months prior to enrolment.

15. Subjects with a chronic pain syndrome and in the judgment of

the Investigator is unlikely to respond to any therapy.

16. Subjects with history of significant trauma or surgery in the

lower limb.

17. History or presence of active rheumatic disease that may be

responsible for secondary knee osteoarthritis.

18. Subjects with history of diabetic neuropathy.

19. Subjects with history of deep vein thrombosis.

20. Subjects with history of major chronic hepatic,

cardiovascular, neurological or immunosuppressive

conditions or the presence of any infections.

21. Subjects with history of bilateral hip joint replacements.

22. Subjects with current use of the following medications:

monoamine oxidase inhibitors, prescription or herbal weight

loss medications/dietary supplement.

23. Any condition that, in the opinion of the investigator, renders

the subject unable to participate in the study.

24. Subjects who smoke or consume tobacco products.

25. Subjects who have been treated with any investigational drug

or investigational device within a period of 3 months prior to

study entry.

26. Subjects who are taking calcium and vitamin D beyond RDA

levels.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
WOMAC IndexTimepoint: Day 84 (week 12)

Secondary Outcome Measures

Name	Time	Method
enduranceTimepoint: Day 84 (week 12);inflammationTimepoint: Day 84 (week 12);joint health by Lequesne IndexTimepoint: Day 84 (week 12);joint health-Lequesne IndexTimepoint: Day 5;joint painTimepoint: Day 5;joint pain - VASTimepoint: Day 84 (week 12);muscle strengthTimepoint: Day 84 (week 12);Quality of Life (QoL)Timepoint: Day 84 (week 12);rescue medicationTimepoint: Day 84 (week 12);serum <br/ ><br>COMP, Serum CTX-II and serum MMP-3Timepoint: Day 84 (week 12);WOMAC IndexTimepoint: Day 5

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