A ROLE OF SHOOLHARA KASHAYA AND KAKAMACHYADI LEPA TREATMENT IN AMAVATA (RHEUMATOID ARHTRITIS)

Phase 4

Not yet recruiting

Conditions: Rheumatoid arthritis with rheumatoid factor without organ or systems involvement. Ayurveda Condition: AMAVATAH,

Registration Number: CTRI/2021/02/031540

Lead Sponsor: All India Institute of Ayurveda

Brief Summary: AYURVEDA is an ancient scientific medical knowledge in the world. It has taken the foremost place in the management of crippling diseases, AMAVATA is one of them. The disease Amavata is a most remarkable problem in the society in modern era. In the whole world Rheumatic disease are commonest cause of physical impairment in society. Due to its wide prevalence chronicity, morbidity, crippling nature and lack of effective drug attract to look for suitable remedy of the disease AMAVATA. In Ayurveda, Amavata was first mentioned by Madhavakara (700AD) as a special disease entity where AMA as well VATA plays an important role in the Samprapti (pathogenesis) of the disease. Here KAPHA and VATA are the main vitiated doshas associated with AMA.Ama a product of impaired Pachakagni and 4 Rasdhatwagni is carried by vayu and accumulated at diffused places of vayu as well as different place of the body mainly in the joints by obstruction of shrotas and cause s inflammation. Vitiated Vayu circulates the Ama all over the body through Dhamanies takes shelter in the shleshmasthan (amashaya, sandhi etc.) producing symptoms such as stiff ness, swelling and tenderness in small and big joints.

Rheumatoid arthritis an auto immune disease is present all over the world with a prevalence of 0.5-1% of adults. There are adequate studies suggesting that current treatment strategies in conventional science with reference to auto immune disease is not satisfactory. The major focus of management is anti-inflammatory and immune suppressive therapy. The response to immune suppression in auto immune disease is seen in 60-70% initially and subsequently the disease may progress or may stop responding to the drug used. Here we are trying to rescue the 7 patient from the adverse side effects of western medicines. Due to formation of Ama there is heaviness of body, poor digestion, lack of vigor. perverted taste, anorexia etc. â– Reason of taking SHOOLHARA KASHAYA because it helps in the management of Amavata by Pachana of Ama,agni deepan,reduces the inflammation along with vitiated Vata and Kapha and also act as rasayan and balya which improves the quality of life of Amavata patients. â– Reason of taking KAKAMACHYADI LEPA processed in ERANDA TAILA in local application because it acts as a good pacifier of vata dosh which causes Vedna (Pain) thatâ€™s why will act as a pain killer ointment

STUDY DESIGN â€“ The study is proposed to be an Open Randomized Double Arm Clinical Trial. The patients with fulfilling diagnostic criteria of AMAVATA (RA) will be taken in two groups. The subject attending the OPD of AIIA will be screened and enrolled in the study following ethic of the Institute and the selection criteria. Study Type - Clinical trial (Analytical and Interventional) Masking - Open Interventional Model â€“ Parallel assignment Timing- Prospective Method of sample selection â€“ Randomized sampling Sample size â€“ A total no. of 60 patients of RA will be taken in the proposed clinical trial, in which they will be divided into 30-30 each in control and trial group. Selection of Cases - O.P.D. /I.P.D. wing of Department of Kayachikitsa, All India Institute of Ayurveda on the basis of diagnostic criteria of Amavata (RA) No. of groups - 2 (Group A â€“ TRIAL GROUP, Group B - CONTROL GROUP)

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

1)Patients having the clinical manifestation of Amavata (RA) according to Ayurvedic classics.
SANDHISHOOL (PAIN), SHOTH (SWELLING), SPARSHASAHTA (TENDERNESS) and STABDHATA (STIFFNESS),Vrishichikadansavata vedana (pain like scorpion sting), Agnimandya (poor digestion) , Aruchi(anorexia), Gaurav(Feeling of heaviness of body),Utsaha Hani(lack of interest),Mukha vairasya(Perverted taste) or having positive RA factor. 2)The 2010 American College of Rheumatology/ European League Against Rheumatism classification criteria for rheumatoid arthritis Score. 3)Classification criteria for RA (score-based algorithm: add score of categories Aâ€“D; a score of 6/10 is needed for classification of a patient as having definite RA). A. Joint involvement â–ª 1 large joint 0 â–ª 2-10 large joints 1 â–ª 1-3 small joints (with or without involvement of large joints) 2 â–ª 4-10 small joints (with or without involvement of large joints) 3 â–ª >10 joints (at least 1 small joints) 5 B. Serology (at least 1 test result is needed for classification) â–ª Negative RF and negative ACPA 0 â–ª Low-positive RF or low-positive ACPA 2 â–ª High-positive RF or high-positive ACPA 3 C. Acute-phase reactants (at least 1 test result is needed for classification) â–ª Normal CRP and normal ESR 0 â–ª Abnormal CRP or abnormal ESR 1 D. Duration of symptoms â–ª <6 weeks 0 â–ª >6 weeks 1 4) Patients willing to participate in the research study.

Exclusion Criteria

1. Patients with other systemic complications of RA like RHD, Rheumatic fever, pleural â€“ pericardial disease.
1. Patients with poorly controlled Hypertension (>160/100 mm of Hg) 3) Patients with Diabetes Mellitus {B.S. (F) > 126 mg% and / or B.S. (2 hr.
PP) >200 mg% OR HbA1c> 6.5%} 4) Patients diagnosed with other arthritis like gouty arthritis, tuberculous arthritis, etc.
1. Patients who are unable to walk without support and / or confined to wheel chair.
1. H/o hypersensitivity to any of the trial drugs or their ingredients.
1. Patients on prolonged (> 6 weeks) medication with antidepressants, anticholinergic, etc.
or any other drugs that may have an influence on the outcome of the study.
1. Pregnant / lactating woman.
1. 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
1)Reduction in VAS Score.	55 Days
2)Providing the Vednahara (analgesic) effect management of Amavata (RA) with Ayurvedic shaman chikitsa.	55 Days

Secondary Outcome Measures

Name	Time	Method
Improvement in the quality of life with the help of questionnaires for scaling of W.H.O quality	of life.

Trial Locations

Locations (1): All India Institute of Ayurveda
🇮🇳
West, DELHI, India
All India Institute of Ayurveda
🇮🇳West, DELHI, India
Dr Archana Shukla
Principal investigator
9643746101
archanashukla9643@gmail.com