"Ayurvedic Management Of Rheumatoid Arthritis .

Completed

Conditions: Rheumatoid arthritis with rheumatoid factor, unspecified,

Registration Number: CTRI/2019/06/019523

Lead Sponsor: Government Ayurved College and Hospital Nagpur

Brief Summary: Rheumatoid Arthritis (RA) is a chronic inflammatory disease of unknown etiology marked by a systemic, peripheral polyarthritis. Rheumatoid Arthritis (RA) is one of the most common forms of chronic inflammatory arthritis and often results in joint damage and physical disability. RA may result in a variety of extra articular manifestation including fatigue, subcutaneous nodules, lung involvement, pericarditis, peripheral neuropathy, vasculitis and hematological abnormalities. Serum antibodies to cyclic citrullinated peptides (Anti CCP) are routinely used along with Rheumatoid factors as a biomarker of diagnostic and prognostic significance

In present era modern medicine prescribes anti-inflammatory Drugs, sometimes steroids are also used. As well as immuno-modulatory agents are also stated. By prescribing these drugs patients have to depend upon drugs for relief. These drugs have hazardous side effects. Apart from these side effects, contracture of joints develops by the time. Thus, patientâ€™s life becomes crippled and treatment is costlier also

*Vagbhata* described complete *Samprapti* of *Vyadhi* and *Sushruta* described it in detail in six stages called as *Shatkriyakala*. As per these stages *Ama* along with *Tridosha* occupies *Shleshmasthana* (*Asthisandhi*) and results in painful disease named as â€œ*Amavata*â€All other also described *samprapti* as above . As per principles of management of *Amavata* given by different writers *Langhana*, *Svedana, Tikta, Dipana, Katu, Virechana, Snehapana,* *Vaitarana* and *Kshar* *Basti* are indicated *Chakrapani* in *Chakradatta* has strongly recommended beneficial role of *Vaitarana* *Basti.*He stressed to administer *Vaitarana* and *Kshara* *Basti* in *Amavata*

The patients will be diagnosed on the basis of American Criteria of Rheumatoid Arthritis as well as signs and symptoms mentioned in classics. The American Criteria of Diagnosis (2010) Keeping this view minimum 100 patients will be registered and out of these at least 80 patients will be selected randomly by using table of random number using Random number table generator. All these patients will be divided into two groups called as Trial Group and Control Group by lottery method. 80 chits of having same size of same color will be done. 40 chits will be titled as trial Group and 40 chits will be Control Group. Patient will be asked to pick up one of chits and will be included in the group labeled on chit

Statistical analysis will be done by considering the quantitative and qualitative data. As per the case, proper tests such as parametric or non-parametric will be evaluated and on the basis of these tests, observations and results will be highlighted accordingly.On the basis of observations and results obtained discussion and conclusion will be described with perspective of *Ayurvedic* concept.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 80

Inclusion Criteria

1. Patients having signs and symptoms of Amavata mentioned in Ayurvedic texts.
1. All patients fulfilling a score of 6/10 is needed for classification of a patient as having definite Rheumatoid Arthritis which is American criteria of Rheumatoid Arthritis (2010).
1. Patients of either sex aged between 25-70 years.
1. Patient willing and able to participate in the study.
1. Patients who have not participated in any research projects since last 6 months.
1. Patients of rheumatoid arthritis having controlled hypertension and Diabetes Mellitus may also be included.
1. Patients of Aamvata having Sama Avastha will only be included in study.

Exclusion Criteria

1. Patients who are not willing for trial.
1. Patients having gross disability in performing daily normal routine i.e. bed ridden patients or confined to a wheel chair or have to take help to perform daily routine activity.
1. Patients having gouty arthritis, syphilitic arthritis, psoriatic arthritis, rheumatic arthritis, tubercular arthritis, gonococcal arthritis etc.
1. Patients with poorly controlled Hypertension.
1. Patients with poorly controlled Diabetes Mellitus.
1. Patients with the evidence of malignancy.
1. Patients on prolonged medication (>6weeks) with corticosteroids, or any other drugs that may have an influence on the outcome of the study.
1. Patients who are currently participating in any other clinical trials (since last 6 months).
1. Pregnant or lactating ladies.
1. Patient with chronicity more than >6 years.
1. Patient with contracture and having deformity in the joints.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Panchasam Churna with Vaitarana Basti will be more effective than Devdarvyadi Churna with Vaitarana Basti in the management of Amavat.	18 months

Secondary Outcome Measures

Name	Time	Method
1.To compare the effect of oral administration of Panchasam Churna with	Vaitarana Basti with that of Devdarvyadi Churna with Vaitarana Basti on clinical features of Amavata and disability index score of Rheumatoid Arthritis

Trial Locations

Locations (1): Government Ayurved College and Hospital Nagpur
🇮🇳
Nagpur, MAHARASHTRA, India
Government Ayurved College and Hospital Nagpur
🇮🇳Nagpur, MAHARASHTRA, India
Dr Rajesh Sahu
Principal investigator
9881124656
drrajeshsahu15@gmail.com