| CTRI Number |
CTRI/2025/03/082233 [Registered on: 12/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical Study To See Effect Of Kwath In Managing Aamavat in reference To Arthritis |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study To Evaluate The Efficacy Of Vaishwanar Kwath In The Management Of Aamavata W.S.R.To 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 Neha Bharat Baviskar |
| Designation |
MD Kayachikitsa Scholar |
| Affiliation |
Dr. VJD Gramin Ayurveda Mahavidyalaya Patur, Akola |
| Address |
Dr.VJD Gramin Ayurved Mahavidyalaya Patur Akola
Akola
MAHARASHTRA
444501
India |
| Phone |
9284286853 |
| Fax |
|
| Email |
nehabaviskar1911@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayashree Katole |
| Designation |
Professor and Head of the Department , Kayachikitsa |
| Affiliation |
Dr. VJD Gramin Ayurveda MahavidyalayaPatur, Akola |
| Address |
OPD No 3 Department of Kayachikitsa Dr VJD Gramin Ayurveda Mahavidyalaya near Renuka Mata Mandir Patur Tal Patur Dist Akola pin code 444501 Maharashtra India
Akola
MAHARASHTRA
444501
India |
| Phone |
9423847608 |
| Fax |
|
| Email |
drjrkatole@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayashree Katole |
| Designation |
Professor and Head of the Department , Kayachikitsa |
| Affiliation |
Dr. VJD Gramin Ayurveda MahavidyalayaPatur, Akola |
| Address |
OPD No 3 Department of Kayachikitsa Dr VJD Gramin Ayurveda Mahavidyalaya near Renuka Mata Mandir Patur Tal Patur Dist Akola pin code 444501 Maharashtra India
Akola
MAHARASHTRA
444501
India |
| Phone |
9423847608 |
| Fax |
|
| Email |
drjrkatole@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Kayachikitsa, Dr VJD Gramin Ayurveda Mahavidyalaya Patur Dist Akola Maharashtra, India pin 444501 |
|
|
Primary Sponsor
|
| Name |
Dr VJD Gramin Ayurveda Mahavidyalaya |
| Address |
Dr. VJD Gramin Ayurveda Mahavidyalaya Near Renuka Mata Mandir Patur Tal _ Patur Dist_ Akola , Maharashtra, India Pin Code _ 444501 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Neha Bharat Baviskar |
Dr. VJD Gramin Ayurved Mahavidyalaya |
OPD no 3 Department of Kayachikitsa, Dr VJD Gramin Ayurveda Mahavidyalaya ,near Renuka mata mandir Patur Tal _ Patur, dist _Akola, Maharashtra
Akola
MAHARASHTRA |
9284286853
nehabaviskar1911@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:M259||Joint disorder, unspecified. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vaishwanar kwath, Reference: Chakradatta Amvat chikitsa 25/15-17, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Rasnapanchak kwath , Reference: Chakradatta Amvat chikitsa 25/7, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients willing for clinical trial.
2)Patient having the sign and symptom of Aamvata.
3)The patients of age group 20 to 60 years will be selected.
4)The patients will be selected irrespective of sex & religion.
5)RA test positive patients. |
|
| ExclusionCriteria |
| Details |
)Patients not willing for clinical trial.
2)Age less than 20 years and more than 60 years.
3)Chronicity more than 5 yr.
4)Any severe deformity.
5)Pregnant woman,lactating mothers.
6) Any other major illness like HIV, AIDS, TB, HTN, DM and malignancy.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Symptoms like1. Sandhishool - Vruschik danshavat vedana
2.Sanchari vedana
3.Sandhishotha
4.Sandhistambha
5.Sandhi sparshasahatva
6.Sandhi aushnya will be decreased and control over Amavata with reference to Rhematoid arthritis |
15 days, 30 days and 45 days after starting treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in symptoms of Amvata |
18 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
18/03/2025 |
| 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 Yet Recruiting |
| 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
|
Ayurveda is a indian system of medicine is the mother of all medical science. It has so many treasures of life that make men disease free healthy and long living. Main objective of the science is to maintain the health of healthy and curing the ailments of ailing. Aamvata is the most common inflammatory joint disorder throughout the world. Aamvata voice recognised as a separate disease only in late 9th century A.D. when Madhavakar describe the distinct etiopathogenesis and symptomatology for it and coined the term Aamvata.Amavasya has been in ayurvedic text into references. 1. to indicate vitiation of vayu with Aam dosha.
2. indicate a disease term as Aamvata Roga a constitutional
disorder with clinical manifestation of joint inflammation.
Vitaited Aam and Vayu by involves koshtha (GIT) ,Trika(L.S.Spines) and sandhi joints creates pain in joints, loss of appetite, indigestion, stiffness of joint ,swelling of joints, weakness and heavyness in chest this condition is known as aamvata. In 21st century rheumatoid arthritis has been more common and distressing among all joints problem. About 0.8% of world population is affected by rheumatoid arthritis. Females are three times more affected than male. It is a chronic employment disease of joint with multi system
environment. The onset is usually during 4th and fifth decade of life. However people of any group can be affected in any climate rheumatoid arthritis make affected person unfit for an independent life. The changing lifestyle of human being by means of dietatic and behaviour pattern place a major role in manifestation of several disorders.Thus this type of pattern may also lead to the development of the disease aamvat. |