Polyherbal Formulation VsGlucosamine and Chondroitin Sulphate forOsteoArthritis in Adults.
- Conditions
- Health Condition 1: M179- Osteoarthritis of knee, unspecified
- Registration Number
- CTRI/2017/12/010838
- Lead Sponsor
- AVN Ayurveda Formulation Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 72
1. Adults between 30 and 60 years of age with confirmed diagnosis or known history of osteoarthritis with moderately active lifestyle (both sexes and ages inclusive)
2.Subject with Grade II or III of Kellergen Lawrence (KL) Grade.
3.Subject with pain (Pain Scale score is 4) on walking in one or both knees 24 hours prior to screening.
4.Subjects with BMI is less than or equal to 30 at the time of screening.
5.Subjects who are ambulatory, requiring but not currently receiving or not satisfied with anti-inflammatory or anti-analgesic drugs
6.Subject/LAR who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during treatment period and follow up period.
7. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
1.Subjects with known hypersensitivity to herbal investigational product or its constituents.
2.Subjects with known hypersensitivity to NSAID, aspirin, COX-2 inhibitors and other analgesic medicine.
3.Subjects who have had hyaluronic acid injections, upto 6 months prior to enrolment.
4.Subjects who have had Intra-Articular Steroid, upto 3 months prior to enrolment.
5.Subjects with immunucompromised state complications.
6.Significant (requiring surgical correction) valgus or varus deformity of the knee, ligamentous laxity, or meniscal instability.
7.Concomitant inflammatory or any other disease/condition which may affect joints (eg, rheumatoid arthritis, metabolic bone disease,psoriasis, gout, pseudogout, chondrocalcinosis etc.).
8.History of sepsis in any joint or any clinical concern for a sub-acute infectious process in the target joint.
9.History of surgery in the target joint.
10.Planned surgery on any lower extremity joint.
11.Clinically significant venous or lymphatic stasis present in the leg(s).
12.Clinically apparent tense effusion or inflammation at the target knee.
13.Any musculoskeletal condition that would impede measurement of efficacy at the target joint
14.Subjects with uncontrolled diabetes, hypertension or congestive heart failure.
15.Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc.), any medical condition that is unstable/poorly controlled or other factor (e.g.,planned relocation) that the Investigator felt would interfere with study evaluations and study participation.
16.Females who are pregnant or lactating or planning to become pregnant during the study period.
17.Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
18.Subjects, who in the opinion of the Investigator or the Medical Experts are not eligible for enrolment in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method