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CTRI Number  CTRI/2024/10/074899 [Registered on: 08/10/2024] Trial Registered Prospectively
Last Modified On: 04/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Comparative Clinical Study in the Management of Rheumatoid Arthritis  
Scientific Title of Study   A Comparative Clinical Study with Udhayabhaskara Ras & Kshara Vasti in the Management of Seropositive & Seronegative Rheumatoid Arthritis W.S.R to Amavata  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kuncharapu Sandhya Rani 
Designation  Post Graduate in KayaChikitsa 
Affiliation  Dr. BRKR Govt Ayurvedic Medical college & Hospital 
Address  Department of Kayachikitsa, Room no 1, Division 1 Dr. BRKR Govt Ayurvedic Medical college & Hospital Erragadda, Hyderabad,
Department of Kayachikitsa, Room no 1, Division 1 Dr. BRKR Govt Ayurvedic Medical college & Hospital Erragadda, Hyderabad, 500018
Hyderabad
TELANGANA
500018
India 
Phone  6303098029  
Fax    
Email  sandhya.kuncharapu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Neredu Umasrinivas Rao 
Designation  Professor, MD Ayurveda, Department of Kaya Chikitsa 
Affiliation  Dr. BRKR Govt Ayurvedic Medical College and Hospital 
Address  Department of Kayachikitsa, Room no 1, Division 1 Dr. BRKR Govt Ayurvedic Medical college & Hospital Erragadda, Hyderabad,

Hyderabad
TELANGANA
500018
India 
Phone  9246346346  
Fax    
Email  dr.nusrao@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Neredu Umasrinivas Rao 
Designation  Professor, MD Ayurveda, Department of Kaya Chikitsa 
Affiliation  Dr. BRKR Govt Ayurvedic Medical College and Hospital 
Address  Department of Kayachikitsa, Room no 1, Division 1 Dr. BRKR Govt Ayurvedic Medical college & Hospital Erragadda, Hyderabad,

Hyderabad
TELANGANA
500018
India 
Phone  9246346346  
Fax    
Email  dr.nusrao@gmail.com  
 
Source of Monetary or Material Support  
Dr. BRKR Govt Ayurvedic Medical college and Hospital, Erragadda, Hyderabad, Telangana, India 500018 
 
Primary Sponsor  
Name  Dr. Kuncharapu Sandhya Rani 
Address  Plot no 84, Krishnanagar colony, Yellareddyguda, Kapra, ECIL, hyderabad, Telangana, 500062 
Type of Sponsor  Other [Self] 
 
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 Kuncharapu Sandhya Rani  Dr. BRKR Government Ayurvedic Medical College and Hospital  Department of Kayachikitsa, Room no 1, Division 1
Hyderabad
TELANGANA 
6303098029

sandhya.kuncharapu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committe Of Dr. BRKR Government Ayurvedic Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M057||Rheumatoid arthritis with rheumatoid factor without organ or systems involvement. Ayurveda Condition: AMAVATAH, (2) ICD-10 Condition:M060||Rheumatoid arthritis without rheumatoid factor. Ayurveda Condition: AMAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-Kshara vasti (Procedure Reference: Chakradatta,Niruhadhikara,73/29-31, Procedure details: In every month, first 7 days kshara vasti will be administered for 3 consecutive months in both groups (A&B) Route-Rectal Dose-360 ml per day for 7 days for 3 months)
(1) Medicine Name: Udhayabhaskara ras, Reference: Vaidhya chintamani 2nd volume,10th chapter-Amavataroga prakaranam, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 125(mg), Frequency: bd, Duration: 90 Days
2Intervention ArmProcedure-Kshara vasti (Procedure Reference: Chakradatta, Niruhadhikara, 73/29-31, Procedure details: In every month, first 7 days shara vasti will be administered for 3 consecutive months in both groups (A&B) Route-Rectal Dose-360 ml per day for 7 days for 3 months))
(1) Medicine Name: Udhayabaskara ras, Reference: Vaidhya chintamani 2nd volume, 10th chapter-Amavataroga prakaranam, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 125(mg), Frequency: bd, Duration: 90 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients with clinical features of Amavata.
2. Patients of either gender, aged between 18 - 65yrs.
3. Patients who fulfill the revised criteria for Rheumatoid arthritis fixed by the American College of Rheumatology.
4. Patients of both RA factor positive and RA factor negative.
5. Patients who are willing to give consent form.
6. Patients who are eligible for kshara vasti. 
 
ExclusionCriteria 
Details  1. Chronicity of more than 10 years.
2. Malignancy & HIV positive patients.
3. Pregnant womens and lactating mothers.
4. Having severe crippling deformities.
5. Systemic diseases like uncontrolled Diabetes, Tuberculosis and Hypertension. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To relieve the symptoms of Rheumatoid Arthritis and improve the quality of life  90 days 
 
Secondary Outcome  
Outcome  TimePoints 
to improve the quality of life by preventing disabilities  90 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 
Date of First Enrollment (India)   15/10/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sandhya.kuncharapu@gmail.com].

  6. For how long will this data be available start date provided 15-10-2024 and end date provided 14-10-2026?
    Response (Others) - 

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
In present time, due to modern lifestyle, hectic schedule, stress, and many such reasons, incidence of diseases are increasing, one of them is Amavata. The concept of autoimmunity is well explained under the concept of Ama, an intermediate product generated due to the deranged metabolism of the digestive fire triggering the chronic inflammatory process in the body.
Rheumatoid arthritis is a chronic inflammatory disease. In the whole world, rheumatic disease is the most common cause of physical impairment in society. The lives of more than one million people are physically impaired by rheumatic disorders and one fifth of them are severely disabled. The prevalence rate of this disease is about 3%, with male female ratio of 1:3. It occurs throughout the world in all climates and ethnic groups.
Madhavakara was the first person to give a detailed description of Amavata. It effects the individuals, who indulge in viruddhahara (improper and irregular dietary habits) viruddha chesta (improper physical and psychological activities) sedentary habits and people who exercise immediately after intake of unctuous food.
The word "Ama" literally means undigested, toxic or unwholesome product, which is produced in the body due to the weakening of digestive fire. This ama is then carried by vitiated vayu and travel throughout the body and gets accumulated in the joints, which is seat of kapha. As this process continues in all joints, it results in severe pain and swelling in the joints. Here pain is due to vitiated vata and swelling is due to vitiated kapha. When pitta also get aggravated, it causes burning sensation in the joints.
Amavata may be correlated with Rheumatoid arthritis, it is a chronic progressive autoimmune arthropathy characterised by bilateral symmetrical involvement of joints with systemic clinical manifestations. It is basically Sero Positive RA & Sero Negative RA. (In Blood RA factor Positive, and Negative)
 
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