Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: Turmeric-Licorice Extract: One capsule containing interventional agent orally twice daily after the meal for 56 days.
Control Intervention1: Placebo: One capsule containing comparator a
Sponsors
Mane Kancor Ingredients Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Participants meeting all the following criteria will be eligible for the study. 1. Male and female participants aged 40-60 years (both inclusive); 2. Suffering from mild to moderate Knee OA (grade II or grade III or Patellofemoral arthritis) on the X-ray imaging 3. Participants willing to participate in clinical trials and who have read understood and signed the informed consent form; 4. A female participant who is of reproductive potential has a negative pregnancy test. 5. No history of substance use disorder other than use of nicotine and recreational use of alcohol (not having used for the last 14 days and consenting not to use the same during the period of the trial);
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will not be eligible for the study. 1. Use of corticosteroids or NSAIDs within 1 week prior to study entry. 2. Known inflammatory or autoimmune joint disorders (e.g., rheumatoid arthritis). 3. Pregnant or lactating women. 4. Participants diagnosed with Kidney stones, Liver diseases, Bleeding, Gall bladder and Gastrointestinal disorders. 5. Participants currently using any nutraceutical, allopathic, or ayurvedic supplement for joint pain. 6. Participants with a history of malignancy diagnosed within the past 5 years or currently diagnosed with malignancy. 7. Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study. 8. Sitting or resting systolic blood pressure above 180 mm Hg or diastolic blood pressure above 110mm Hg at screening. 9. Uncontrollable diabetes (HbA1c above 9%). 10. Participants with a history of substance abuse, drugs, heavy use of alcohol, and/or smoking within last 5 years; 11. Serious illness or any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the participant or preclude the successful completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain, stiffness and function subscales score from baseline to Day 15, 29, 43, 57, 63 2. Visual Analog Scale (VAS) from baseline to Day 15, 29, 43, 57, 63. Timepoint: Screening, Day 15, 29, 43, 57, 63. | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum hs-CRP, CBC, ESRTimepoint: Screening and 57th day. | — |
Countries
India
Contacts
Public ContactDr Sherena P A
Mane Kancor Ingredients Private Limited
Outcome results
None listed