EFFECT OF RASNADI GUTIKA AND CHANDRAKALA LEPA IN OSTEOARTHRITIS KNEE

Phase 3

Completed

Conditions: PAIN AND STIFFNESS OF THE KNEE JOINTS

Registration Number: CTRI/2015/01/005414

Lead Sponsor: CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES JANAKPURI NEW DELHI

Brief Summary: THE TRIAL IS IN THE EARLY PHASE AND IS NOT YET STARTED. The present study the drugs Rasnadi Gutika (Ref:AFI, Part-III, Page-111) contains Rasna, Guggulu and Sarpi. According to Ayurveda, Rasna is a well known drug for Vatashamana (which alleviates Vata). Moreover itâ€™s anti-inflammatory, analgesic, immunostimulating and antioxidant effect also have been reported. (IJNPR Vol.-I(2)[Junw-2010]). Guggulu is also Vatahara (subsides the aggravated Vata dosha), Shulahara (relieves pain) and itâ€™s anti-inflammatory activity and effectiveness in Osteoarthritis has been reported. (Alternative therapies in health and Medicine, May/June,2003, Vol.-9, No.3). Sarpi is Vata Shamaka, and Brumhaniya(Ca.Su. 13/4).Chandrakala Lepa (Ref:AFI, Part-III, Page-225) contains Madhuchhista, Sveta Maricha, Coconut Oil, and Karpura. Madhuchhista and Coconut Oil, being snigdha (unctuous) in nature decreases rukshata (roughness) in the joints. Sveta Maricha and Karpoora, both are shula nashaka (relieves pain) and can act effectively in Sandhivata.

Warm Water (as anupana) is Vatahara (subsides the aggravated Vata dosha) and Shulanashaka (relieves pain). Due to its Ushna (hot nature) and Teekshna (sharpness) properties, it acts as Sroto shodhaka (make clarity of the channels in the body), by which Vata anulomana (subside of aggravated Vata dosha) occurs and it helps the drugs to act properly in the proper site.

Therefore both the above drugs are taken into the specific disease condition with the hypothesis that, to act effectively for the proper Samprapti vighatana (disintegration of the pathogenesis of the disease), by alleviating Vata and Shula, which are the main complaints of the disease.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

1)Patients of either sex aged between 40 and 75 years.
2)Patient with primary osteoarthritis Knee joint(s) fulfilling the diagnostic criteria of osteoarthritis recommended by the American College of Rheumatology; i.e. Knee pain and; At least three of the following 6 criteria: 50 years of age or older, stiffness lasting less than 30 minutes, crepitus, bony tenderness, bony enlargement, no warmth to the touch 3)Pain in the affected Knee joint(s) > 3 months (with radiological changes as per Grade I to III of Kellgren & Lawrence Radiological scale) i.e. Grade 1: Narrowing is defined as doubtful narrowing of joint space and possible osteophytic lipping.
Grade 2: Osteophytes and definite narrowing of joint space.
Grade 3: Moderate multiple osteophytes, definite narrowing of joint space, some sclerosis and possible deformity of bone ends.
4)Willing and able to participate in the study for 03 months.

Exclusion Criteria

1.Patients with Grade IV Kellgren & Lawrence Radiological scale i.e. Grade 4: Large osteophytes, marked narrowing of joint space, severe sclerosis and definite deformity of bone contour.
2.History of any trauma/ fractured joint / surgical/diagnostic intervention with reference to the affected joint(s).
3.Gross disability in performing daily normal routine i.e. bed ridden patients or confined to a wheelchair.
4.Patients with co morbidities such as gouty arthritis, rheumatoid arthritis and psoriatic arthritis.
5.Patients having any deformity of knee hip or back altering the gait and posture of the patient.
6.Patients with Unstable cardiovascular diseases.
7.Patients with uncontrolled diabetes mellitus {HbA1c>6.5%}.
8.Patients with evidence of malignancy.
9.Patients on prolonged (> 6 weeks) medication with corticosteroids, antidepressants, anticholinergics, etc.
or any other drugs that may have an influence on the outcome of the study.
11.Pregnant / lactating woman.
12.Patients who have participated in other clinical trials within two months of duration.
13.Any other condition which the Principal Investigator thinks may jeopardize the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
â€¢Change in WOMAC total score(CRD, Pune version) (At the time of baseline and at the end of the treatment).	Total Study Period24 months \| Preparatory Period 3 months \| Recruitment 18 months \| Treatment Period3 months \| Statistical Analysis 3 months

Secondary Outcome Measures

Name	Time	Method
â€¢Change in WOMAC stiffness Domain Score	â€¢Change in WOMAC Physical function Domain .

Trial Locations

Locations (2): NATIONAL RESEARCH INSTITUTE OF AYURVEDA DRUG DEVELOPMENT, BHUBANESWAR
🇮🇳
Khordha, ORISSA, India
NATIONAL VETERINARY AYURVEDIC RESEARCH INSTITUTE & HOSPITAL, LUCKNOW
🇮🇳
Lucknow, UTTAR PRADESH, India
NATIONAL RESEARCH INSTITUTE OF AYURVEDA DRUG DEVELOPMENT, BHUBANESWAR
🇮🇳Khordha, ORISSA, India
DR BANAMALI DAS
Principal investigator
9439956684
banamali.d@gmail.com