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CTRI Number  CTRI/2022/05/042860 [Registered on: 27/05/2022] Trial Registered Prospectively
Last Modified On: 25/05/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of ayurveda interventions in the management of ‘Amavata’ with special reference to Rheumatoid Arthritis.  
Scientific Title of Study   Evaluation of Ayurvedic interventions in the management of ‘Amavata’ W.S.R. to Rheumatoid Arthritis- a quasi interrupted time series design 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nikita Sharma 
Designation  PG Scholar  
Affiliation  National institute of Ayurveda Deemed to be University Jaipur 
Address  National institute of Ayurveda Deemed to be University Near jorawar singh gate Amer road Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  8741097165  
Fax  0  
Email  niksharma1641996@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr HML Meena 
Designation  Associate Professor 
Affiliation  National institute of Ayurveda Deemed to be University Jaipur 
Address  National institute of Ayurveda Deemed to be University Near jorawar singh gate Amer road Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9461297017  
Fax  -  
Email  hari_mohan68@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  DR Nikita Sharma 
Designation  PG Scholar  
Affiliation  National institute of Ayurveda Deemed to be University Jaipur 
Address  National institute of Ayurveda Deemed to be University Near jorawar singh gate Amer road Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  8741097165  
Fax  -  
Email  niksharma1641996@gmail.com  
 
Source of Monetary or Material Support  
National institute of ayurveda deemed to be university jaipur  
 
Primary Sponsor  
Name  National institute of ayurveda deemed to be university jaipur 
Address  jorawar singh gate amer road jaipur rajasthan 302002 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nikita Sharma  National institute of ayurveda deemed to be university jaipur  Department of kayachikitsa, National institute of ayurveda jorawar singh gate amer road 302002
Jaipur
RAJASTHAN 		 8741097165
-
niksharma1641996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE OF NATIONAL INSTITUTE OF AYURVEDA JAIPUR   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M069||Rheumatoid arthritis, unspecified. Ayurveda Condition: AMAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Rasnasaptaka Kwatha, Reference: Bhaisajya Ratnavali 29/25, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 42 Days, anupAna/sahapAna: No, Additional Information: Sunthi-Guduchi Siddha Jala 1 litre per day Throughout day whenever thirst and Ruksh baluka swedan 10 min Morning and evening.
2Intervention ArmDrugClassical(1) Medicine Name: VaishwanaraChurna, Reference: Bhaisajya Ratnavali 29/48-51, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Ushna Jala), Additional Information: Sunthi-Guduchi Siddha Jala 1 litre per day Throughout day whenever thirst and Ruksh baluka swedan 10 min Morning and evening.
3Intervention ArmDrugClassical(1) Medicine Name: Simhanada Guggulu, Reference: Ayurveda- sarasangrah guggulu prakaran, Route: Oral, Dosage Form: Guggulu , Dose: 1.5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 42 Days, anupAna/sahapAna: Yes(details: Rasnasaptaka Kwatha ), Additional Information: Sunthi-Guduchi Siddha Jala 1 litre per day Throughout day whenever thirst and Ruksh baluka swedan 10 min Morning and evening.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients willing to sign consent form for the clinical trial.
2. Patients between the age group of 18 to 60 years, irrespective of sex and socio-economic status.
3. Patients having signs and symptoms of ‘Amavata’ (Rheumatoid Arthritis)
4. Patients fulfill the criteria of ACR/ EULAR 2010 criteria (American College of Rheumatology/ European League Against Rheumatism)
5. Patients with chronicity of less than 5 years. 
 
ExclusionCriteria 
Details  1. Patients having severe joint deformities.
2. Patients suffering from paralysis.
3. Patients having any type of arthropathy such as Neoplasm of spine, Gout, Ankylosing spondylosis, Traumatic arthritis and Pyogenic osteomyelitis etc.
4. Patients having associated Cardiac disease, Tuberculosis, Diabetes mellitus, Malignant Hypertension, Renal Function Impairment, Hypothyroidism, Rheumatic Heart Disease etc.
5. Patients with extremely reduced joint space.
6. Pregnant women and lactating mother.
7. Patient taking disease modifying anti-rheumatic drugs (DMARDs) for rheumatoid arthritis.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in DAS- 28 score.   56 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in symptoms of Amavata, Improvement in quality of life and changes in CRP, RA Factor, Disability Index Score, other symptoms, Improvement in walking time, hand & foot grip.  56 Days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/06/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

INTRODUCTION:

‘Amavata’ as a separate disease entity was described for the first time in detail by Acharya Madhav Kara (700 A.D.) who devoted a full chapter of Amavata in his famous monograph ‘Madhava Nidana’. He mentioned etiopathogenesis of Amavata in systemic manner besides the signs, symptoms, complications and prognosis. In Brahtriya, there is no description regarding Amavataas a separate disease entity.

The changing lifestyle of human being by means of dieteric and behavious pattern plays a major role in the manifestation of the disease Amavata. Though all the Doshastake part in the causation of this disease, Ama and Vitiated vata play the dominant role. Amavata is disease of Rasavaha srotasaand it is the outcome of Agnidushti, Amotpatti and Sandhivikruti.

First the disturbance in function of Agni (Jatharagnimandya, dhatvagnimandya, bhutagnimandya and malasanchaya) occurs in body and leads to formation of Ama in body. Vitiated Vayucirculates the Amaall over the body through Dhamanis, takes, which shelter in the Shleshmasthana (Amashaya, Sandhi etc.), producing symptoms like swelling, tenderness and stiffness in small and big joints. Here it mixes with vata, pitta and kapha acquires variative colours and becomes viscous. Due to this process, symptoms of Amavata such as Daurbalya, Jadyata and Hridgaurava occur1.

The symptoms of Amavata are identical to rheumatoid arthritis. It is an auto immune disorder which has significant parlance with Amavata. It is one of the common developing disease because of its chronicity and implications.

There are good numbers of drugs describes in Ayurvedic classics for the management of Amavata. The trial drugs selected for the study is:

· Vaishwanara Churna mentioned in Bhaishajya Ratnavali2 (29/ 48-51),

· Sinhanada Guggulu3 mentioned in Ayurveda sara sangrah (guggulu prakaran)and

· Rasnasaptaka Kwatha mentioned in Bhaishajya Ratnavali4 (29/ 25) in Amavata Chikitsa.

NEED OF THE STUDY:

Many people in society are unaware about this disease and its complications which is responsible for life long joint deformities. Many Ayurvedic preparations are mentioned in Samhita which are very effective in the treatment of Amavata. Amavata(rheumatoid arthritis) has been a challenging problem to the medical field. The lives of more than 1 million people are physically impaired by rheumatoid arthritis. Due to its wide prevalence of morbidity and lack of effective drugs, it is need of time to find out effective solution in the management of Amavata (rheumatoid arthritis).

A lot of research work has already been done on treatment of Amavata in both modern and Ayurveda sciences and lots of still going on. By looking into the above-mentioned facts, there is a need for a treatment which can prevent complication of the disease as well as improves quality of life of patients.

The treatment of Amavata is very expensive and modern medications have serious side effects also.Due to wide spectrum and much prevalence of the disease and lack of effective medical treatments, the disease is being chosen for the study.

The line of treatment described for the disease in Ayurveda is-6

“लंघनंस्वेदनंतिक्तंदीपनानिकटूनिच।

विरेचनंस्नेहपानंबस्तयश्चाममारुते।

सैधवाद्येनानुवासस्यक्षारबस्ति: प्रशस्यते”।।

(चक्रदत्तआमवातचिकित्साप्रकरण २५/१)

 
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