An effectiveness and safety study of Pork Skin Collagen Peptide (SCP- α) as add-on nutritional therapy in subjects with knee joint osteoarthritis.

Phase 3

Completed

• Conditions: Health Condition 1: M179- Osteoarthritis of knee, unspecified

• Registration Number: CTRI/2009/091/000993
• Lead Sponsor: MS Nitta Gelatin India Limited Cochin India

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

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

?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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
?To measure and evaluate ?WOMAC? pain sub-scale scores over 14 weeks. <br/ ><br>?To measure and evaluate the ?Pain VAS scores? ? on walking over 14 weeks. <br/ ><br>Timepoint: 14 weeks

Secondary Outcome Measures

Name	Time	Method
?To measure and evaluate the ?Quality of life over 14 weeks. <br/ ><br>?To evaluate the changes in the ?X-ray findings? (Weight bearing X-ray) of knee joint osteoarthritis after 14 weeks. <br/ ><br>Timepoint: 14 weeks