| CTRI Number |
CTRI/2024/10/075735 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
17/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Vidangadi kwatha and Eranda Shunthee yog in the management of Aamvata |
|
Scientific Title of Study
|
An Open Randomized Comparative clinical study of Vidangadi kwatha with Eranda Shunthee yog in the management of Aamvata |
| 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 Suman Sunil Kawade |
| Designation |
Post graduate resident |
| Affiliation |
APMs Ayurved Mahavidyalaya sion near sion railway station Mumbai Mumbai 400022 |
| Address |
APMs Ayurved Mahavidyalaya sion near sion railway station Mumbai
Mumbai
400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9146486718 |
| Fax |
|
| Email |
sumankawade005@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anaya Ashish Pathrikar |
| Designation |
Professor and HOD |
| Affiliation |
APMs Ayurved Mahavidyalaya sion near sion railway station Mumbai Mumbai 400022 |
| Address |
Department of kayachikitsa
APMs Ayurved Mahavidyalaya sion near sion railway station Mumbai
Mumbai
400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9870214595 |
| Fax |
|
| Email |
anayapatrikar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anaya Ashish Pathrikar |
| Designation |
Professor and HOD |
| Affiliation |
APMs Ayurved Mahavidyalaya sion near sion railway station Mumbai Mumbai 400022 |
| Address |
Department of kayachikitsa
APMs Ayurved Mahavidyalaya sion near sion railway station Mumbai
Mumbai
400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9870214595 |
| Fax |
|
| Email |
anayapatrikar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurveda Prasarak mandal and seth RV hospital |
|
|
Primary Sponsor
|
| Name |
Suman Sunil Kawade |
| Address |
APMs Ayurved Mahavidyalaya sion near sion railway station sion
Mumbai 400022 |
| 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 Suman Sunil Kawade |
APMs Ayurved Mahavidyalaya and seth R V Ayurved Hospital Sion Mumbai |
APMs Ayurved
Mahavidyalaya and
Seth R V Ayurved
Hospital near Sion
railway station Sion
Mumbai 400022
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
9146486718
sumankawade005@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| APMs Ayurved Mahavidyalaya Sion IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M069||Rheumatoid arthritis, unspecified. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vidgadi kwatha, Reference: Harit samhita 19/34-35, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: 10ml eranda taila and 10ml dugdha), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Eranda shuntee yog, Reference: -, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Shuntee yog), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient in the age group of 16 yearsto 70 years
2. Patients of all genders will be included.
3. Patients having classicalsigns and symptoms of Aamvata |
|
| ExclusionCriteria |
| Details |
1.Pregnant women and lactating mothers.
2. Serioussystemic disorders known case of Diabetes mellitus, Malignancy,
3. Renal failure.
4. If patient is not willing |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Complete Blood Count (CBC)
Erythrocyte Sedimentation Rate (ESR)
C Reactive Protein (CRP)
Visual Analogue Scale (VAS) |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Angamarda (body ache)
Aruchi (Anorexia)
Trishna(excessive thirst)
Alasya (lethargy)
Angi Dourbalya (loss of
digestive fire)
Vairsyata (Impairement in
taste)
Gouravata( Heavinessin
the body)
Bahu mutrata (Increased
frequency of urine)
Daha (Burning sensation)
Kukshi kathinya (Hardness
of abdomen)
Jadya ( stiffness of body)
Jwara ev prachiti
Sandhishula (Pain in joints)
Sandhijadyata (stiffness in
joints)
Sandhishotha (Swelling in
joints)
Malavstambhata |
14 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/11/2024 |
| Date of Study Completion (India) |
16/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 chronic disease, rasavaha srotas vyadhi and one of the autoimmune disease. As it is not completely curable, it is manageable.It requires a long term treatment and pathya palan . Main couse of amavata is ama which accumulates in the body . With the help of Laghan, deepen, pachan ,pachan of ama is done and after ,pachan it is removed from body with virechan.So whenever aam sanchiti in body like in eg.vasanta, varsha ritu virechan can be given periodically . For all these purposes Vidangadi kwatha is selected for this study. There are several Ayurvedic preparations for treating Amavata that can be used both internally and externally. It is necessary to study and evaluate efficacy of medications by scientific research. Vidangadi kwatha contents vidanga ,rasna,shunthee,haritaki,trikatu and anupan eranda and godugdha, all these dravya will follow the chikitsa sutra to virechana karma.and it is useful for amavata. |