| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | 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 | | 2 | Intervention Arm | Procedure | - | 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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sandhya.kuncharapu@gmail.com].
- For how long will this data be available start date provided 15-10-2024 and end date provided 14-10-2026?
Response (Others) -
- 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) |