| CTRI Number |
CTRI/2025/04/085603 [Registered on: 24/04/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Panchakarma] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Virechana followed by Snehapana in Amavata Rheumatoid Arthritis |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of Virechana karma followed by Shamana Snehapana with Amrita Shunthi Ghrita in the management of Amavata w.s.r. Rheumatoid Arthritis. |
| 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 Pranav Pandya |
| Designation |
PG Scholar of Panchakarma Department |
| Affiliation |
Government Akhandanad Ayurved College and Hospital, Ahmedabad |
| Address |
OPD No 5 Panchakarma Department Government Akhandanand Ayurved College and Hospital Bhadra Ahmedabad 380001
OPD No 5 Panchakarma Department Government Akhandanand Ayurved College and Hospital Bhadra Ahmedabad 380001
Ahmadabad
GUJARAT
380001
India |
| Phone |
9173677855 |
| Fax |
|
| Email |
pranavpandya791@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krupali Raut |
| Designation |
Reader of Panchakarma Department |
| Affiliation |
Government Akhandanad Ayurved College and Hospital, Ahmedabad |
| Address |
OPD No 5 Panchakarma Department Government Akhandanand Ayurved College and Hospital Bhadra Ahmedabad 380001
OPD No 5 Panchakarma Department Government Akhandanand Ayurved College and Hospital Bhadra Ahmedabad 380001
Ahmadabad
GUJARAT
380001
India |
| Phone |
9427149250 |
| Fax |
|
| Email |
rautkajal77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pranav Pandya |
| Designation |
PG Scholar of Panchakarma Department |
| Affiliation |
Government Akhandanad Ayurved College & Hospital, Ahmedabad |
| Address |
OPD No 5 Panchakarma Department Government Akhandanand Ayurved College and Hospital Bhadra Ahmedabad 380001
OPD No 5 Panchakarma Department Government Akhandanand Ayurved College & Hospital Bhadra Ahmedabad 380001
Ahmadabad
GUJARAT
380001
India |
| Phone |
9173677855 |
| Fax |
|
| Email |
pranavpandya791@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Akhandanand Ayurved College Bhadra Ahmedabad Gujarat India 380001 |
|
|
Primary Sponsor
|
| Name |
Government Akhandanand Ayurved College, Ahmedabad |
| Address |
OPD No.5, Department of Panchakarma, Government Akhandanand Ayurved College and Hospital, Bhadra, Ahmedbad, Gujarat, India 380001 |
| Type of Sponsor |
Government medical college |
|
|
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 Pranav Pandya |
Government Akhandanand Ayurved College And Hospital |
OPD NO 5 Department Of Panchakarma Government Akhandanand Ayurved College And Hospital Bhadra Ahmedabad Gujarat India 380001
Ahmadabad
GUJARAT |
9173677855
pranavpandya791@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M059||Rheumatoid arthritis with rheumatoid factor, unspecified. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-कर्म | (Procedure Reference: Bhaishajya Ratnavali, Procedure details: Purva Karma
Dipana & Pachana
Drug Vaishvaner Churna
Dose 10 to 12 gm per day 5 to 6 gm twice a day as
per Aatura Agni
Time of Administration Before Food
Anupana Ushna Jala
Route of Administration Oral Route 5 to 15 Days till the appearance of Nirama Dosha Lakshana achieved
Snehapana
Drug Amrita Shunthi Ghrita
Dose - 25-50 ml starting dose in vardhamana Krama as per Aatura-Kostha & Agni
Time of Administration Early Morning an empty stomach
Anupana Ushna Jala
Route Oral Route
Diet Light Diet drava ushna anabhishyandi natisnidgha asankirna 3 to 7 Days Depending upon the Appearance of Samyak Snigdha Lakshana
Mridu Abhyanga & Bashpa Sweda
Drug Saindhavadi Taila Q S Approx 50 ml
For 1st 2nd 3rd day during vishrama kala after completion of abhyantar snehapana & also 4th day prior to Virechana karma 4 days
Pradhana Karma
Virechana Karma
Drug Tivrutt Churna & Shunthi Churna & Saindhava Lavana
Dose 15 to 45 gm
Anupana Aranala 60 to 180 ml
Route Oral Route
Time of Administration Sleshma kale gate Anannam After 10 am Empty Stomach 1 day
Paschata Karma
Samsarjana Karma
Diet Plan will be fixed as per shuddhi will for 3 to 7 days
The regimen of 7 or 5 or 3 days will be fixed according to the Pravar Madhyama Avara Shuddhi
The sequence of Peya Vilepi Akrit Mudga Yusha & Odana Krita Mudga Yusha & Odana will be served for 3 or 2 or 1 aaharakala According to the type of shuddhi
All these food preparation will be prepared according to the method described in the classics of Ayurveda 3 to 7 days
Shamana Snehapana
Drug Amrita Shunthi Ghrita
Dose 30 to 50 ml
Anupana Ushnodaka
Route Oral route 14 days
)
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Either sex with age greater than or equal to 18 years and less than or equal to 60 years
The Willingness and able to participate of the patients in the study
Patient having signs and symptoms of Amavata Rheumatoid arthritis with fulfilling Diagnostic criteria
Chronicity less than 10 years and more than 1 year |
|
| ExclusionCriteria |
| Details |
Patients below 18 years and above 60 years
Pregnant or lactating women
Snehana Ayogya patients
Virechana Ayogya patients
Chronicity More than 10 years
Known Case of Severe Heart Diseases Kidney Diseases Stroke Liver Diseases Uncontrolled diabetes and Carcinogenic conditions
Known Case Of Pulmonary Dysfunction or COPD
History of any acute or chronic infectious diseases like TB AIDS Other STDs
Taking medications like corticosteroids hormonal therapy Anti depressants or any other drugs which may affect outcome of the study
With alcohol addiction or drug abuse
Acute Amavata less than 1 year |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the symptoms of Amavata wsr Rheumatoid Arthritis |
30 to 48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in the symptoms of Amavata wsr Rheumatoid Arthritis |
5th to 15th day
8th to 22nd day
12th to 26th day
15th to 33rd day
30th to 48th day |
|
|
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)
|
05/05/2025 |
| 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 - NO
|
|
Brief Summary
|
Amavata is the particular type of disease which is the mentioned in Ayurveda since the period of Madhavakara 16th century A.D. under the category of Vata Kaphaja disorders. Amavata develops due to Dushti or Prakopa of Ama as well as Vata dosha. The clinical presentation of Amavata closely mimics with the special variety of rheumetological disorders called rheumatoid arthritis (R.A.), in accordance with their similaritis on clinical features, like pain , swelling .stiffness, fever, redness, general debility are almost identical.The rheumatological disorder is such a group of diseases which has no specific medical management in any type of therapeutics. Amavata is the prime disease which makes the person unfit for an independent life and about 60% of the patients become unfit to work 10 years after the onset of the disease. The Ayurvedic approach toward the treatment of Amavata is the need of our as no system is successful in providing a complete cure to this disease For the treatment of Amavata Acharya Chakradutta and Acharya Bhavmishra explained that Langhana, Swedana , Dipana with Tikta and Katu Rasapradhan dravya and Virechana followed by Shamana Snehpana After Langhana, Swedana and Tika, Katu, Deepana dravyas, doshas Attain nirama avastha and may require elimination from the body by shodhana. Symptoms of Amavata like Anaha, vibandha, Antrakujana, kukshishula etc. are indicated of pratiloma gati of vata. This is best conquered by Virechana. Dipana Yoga (Vaishvaner Churna) having Tikta and Katu rasatmaka, Ushna,Tikshna, Sukshma, gunatmaka.They have qualities of Dipana , Pachana and Anulomaka, which helps in the Pachana of Ama and subsides the aggravate Vata dosha. Amrita Shunthi Ghrita is for Shodhanartha helps to subsides Amavata and prepare the body for Virechana to carry the doshas from Shakha to Kostha.
Virechana with Trvrittadi churna is recommended treatment for Amavata after Deepana Pachana which also helps to subsides aggravated vata in Amavata. Acharya Vagbhata mentioned in Sutrasthana chapter 16 that after Shodhan karma, Snehana should be advised for Bala.
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