Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: Collagen peptide- SCP-alpha of pork skin origin: oral powder
10gm/day
13 weeks
Control Intervention1: Placebo: oral powder
13 weeks
Sponsors
MS Nitta Gelatin India Limited Cochin India
Aurous HealthCare Research and Development India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: ? Subjects of both sexes between 30 and 65 years of age. ? Subjects who are willing to give informed consent. ? Subjects who are willing to comply with the study procedure. ? Subjects having a medical history of knee joint osteoarthritis. ? Subjects who are already not on NSAIDs 7 days prior to screening. ? Subjects willing to use pain relieving medications as prescribed by the physician in the trial. ? Subjects diagnosed with knee joint osteoarthritis fulfilling the ACR classification criteria for knee joint osteoarthritis. ? Subjects with a pain (VAS score ≥ 4) in one or both knees on walking during the 24 hours preceding recruitment. ? Subjects with moderate radio graphic evidence by Kellgren - Lawrence grade 2 to grade 4. ? Otherwise, the subject in generally good health as judged by investigator.
Exclusion criteria
Exclusion criteria: ? Subjects who are diagnosed with OA excepting knee joint osteoarthritis. ? Subjects who are suffering from systemic diseases. . Subjects with BMI of more than 35. ? Subjects with known history of hypersensitivity or intolerance to NSAIDs and any other analgesic medicine. ? Subjects who are incapacitated or bound to wheel chair or bed and unable to carry out self care activities. ? Subjects who have undergone treatment with intra-articular injection of corticosteroids into the knee within 3 months preceding the study. ? Pregnancy, lactation and women of child bearing potential not following an acceptable contraceptive measure. ? Subjects with pre-existing or recent onset of demyelinating disorders or diabetes. ? Subjects with presence or history of active peptic ulcer in the preceding 5 months or bleeding ulcer at anytime in the past. ? Subjects suffering or having a previous medical history of gout. ? Subjects who have evidence of severe renal, hepatic or hemopoietic disease or moderate to severe cardiac conditions revealed by laboratory investigations or other tests. ? Subjects who used Ayurvedic formulation or any form of CAM (Complementary Alternative Medicine) therapy in the preceding 2-3 months ? Subjects who are using steroids, antipyretics, tranquilizers and hypnotics during the trial. ? Subjects who are using concurrent pain relieving medication other than prescribed in the trial. ? Subjects using glucosamine, chondroitin, doxycycline or any other anti-osteoarthritis preparation within 14 days prior to randomization. ? Subjects who underwent arthroplasty for the knee. ? Subjects with history of chronic alcoholism or subjects who consumed alcohol 48 hours prior to enrollment. ? Subjects having a history of smoking 5 cigarettes or more per day ? Subjects who participated in any other clinical trial 3 months prior to this trial. ? Subjects who are unwilling or unable to comply with the study procedures. ? Subjects, for any reason who are considered to be unsuitable candidates by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ? To measure and evaluate ?WOMAC? pain sub-scale scores over 14 weeks. ? To measure and evaluate the ?Pain VAS scores? ? on walking over 14 weeks. Timepoint: 14 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| ? To measure and evaluate the ?Quality of life over 14 weeks. ? To evaluate the changes in the ?X-ray findings? (Weight bearing X-ray) of knee joint osteoarthritis after 14 weeks. Timepoint: 14 weeks | — |
Countries
India
Contacts
Public ContactDrVTSriraam
Aurous HealthCare R&D India Pvt Ltd
Outcome results
None listed