Do Ayurveda formulations help in the management of Joint Pain?
- Conditions
- Health Condition 1: null- Rheumatoid Arthritis
- Registration Number
- CTRI/2017/11/010615
- Lead Sponsor
- All India institute of Ayurveda
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 64
1. Patients having classical features of Amavata (Angamarda, Aruchi, Trishna, Alasya, Gaurava, Jwara, Apaka, Shoonata anganam)
2. Patients having the Pratyatma lakshana of Amavata (Shotha, Sandhi ruja, Sandhi graha, Sarwanga / Ekanga Sandhi Sotha, Arati)
3. Pravriddha Lakshana of Amavata (Agni daurbalya, Praseka, Aruchi, Gaurava, Vairasya, Ruja and Shotha in Hasta, Pada, Shiro, Gulpha, Trika, Janu, Uru Sandhi, Vrishchika Danshavat Vedana, Kukshi kathinya, Kukshi shula, Vibandha, Anaha, Hritgraha, Antra kujana, Chhardi, Jadya, Bhrama, Murchcha, Nidra-Viparyaya, Daha, Bahumutrata)
4. ARA Criteria - Patients who have at least one joint with definite clinical synovitis (swelling) with the synovitis not better explained by another disease
1. Patients with other systemic complications of RA like RHD, Rheumatic fever, pleural â?? pericardial disease. Patients with poorly controlled Hypertension ( >160/100 mm of Hg)
2. Patients with Diabetes Mellitus (Fasting blood sugar more than 126 mg% and / or Post Prandial blood sugar more than 200 mg% OR HbA1c > 6.5%}
3. Patients diagnosed with other arthritis like gouty arthritis, tuberculous arthritis etc.
4. Patients who are unable to walk without support and / or confined to wheel chair.
5. Patients on prolonged ( > 6 weeks) medication with corticosteroids, antidepressants, anticholinergic, etc. or any other drugs that may have an influence on the outcome of the study
6. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
7. Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2 times upper normal limit) or Renal Disorders (defined as Creatinine >1.2mg/Dl), Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), or any other condition that may jeopardize the study.
8. Alcoholics and/or drug abusers.
9. H/o hypersensitivity to any of the trial drugs or their ingredients.
10. Pregnant / lactating woman.
11. Patients who have completed participation in any other clinical trial during the past 6 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relief in cardinal signs and symptoms.Timepoint: 1 month.
- Secondary Outcome Measures
Name Time Method Improvement in Quality of LifeTimepoint: One Month