| CTRI Number |
CTRI/2025/07/091010 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
27/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The management of Amvata (Rheumatoid arthritis )with Kshar basti helps better in treatment. |
|
Scientific Title of Study
|
Randomized open controlled clinical study to evaluate the efficacy of Kshar basti in the management of Amvata 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 |
Vaishnavi Sanjayrao Itolikar |
| Designation |
PG Scholar |
| Affiliation |
Yashwant ayurvedic college post graduate training and research centre, Kodoli. |
| Address |
Yashwant ayurvedic college post graduate training and research centre, panchkarma department OPD Kodoli, Tal. Panhala, Dist. Kolhapur, State Maharashtra, 416114,India.
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8788183921 |
| Fax |
|
| Email |
itolikarvaishnavi28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravikumar Bhagwan Patil |
| Designation |
MD PhD Panchkarma Professor and HOD of Panchkarma Department |
| Affiliation |
Yashwant ayurvedic college post graduate training and research centre, Kodoli. |
| Address |
Yashwant ayurvedic college post graduate training and research centre, panchkarma department OPD Kodoli, Tal. Panhala, Dist. Kolhapur, State Maharashtra, 416114,India.
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9822010316 |
| Fax |
|
| Email |
vaidyaravipatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrVaishnavi Sanjayrao Itolikar |
| Designation |
PG Scholar |
| Affiliation |
Yashwant ayurvedic college post graduate training and research centre, Kodoli. |
| Address |
Yashwant ayurvedic college post graduate training and research centre, panchkarma department OPD Kodoli, Tal. Panhala, Dist. Kolhapur, State Maharashtra, 416114,India.
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8788183921 |
| Fax |
|
| Email |
itolikarvaishnavi28@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Kodoli Tal Panhala Dist Kolhapur 416114 |
|
|
Primary Sponsor
|
| Name |
Dr.Vaishnavi Sanjayrao Itolikar |
| Address |
Panchkarma OPD and Ipd Ground floor Panchakarma dept Yashwant Ayurvedic
College Post Graduate Training and Research Centre Kodoli Kodoli Tal Panhala Dist Kolhapur 416114 |
| 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 |
| DrVaishnavi Sanjayrao Itolikar |
Yashwant Dharmartha Rugnalay |
Yashwant Ayurvedic College
Post GraduateTraining and
Research Centre, Kodoli
Panchkarma OPD Ground floor
and IPD Second floor, Room No.
4 Panchakarma department.
Kodoli Tal Panhala Dist Kolhapur 416114
Kolhapur
MAHARASHTRA |
8788183921
itolikarvaishnavi28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M180||Bilateral primary osteoarthritis of first carpometacarpal joints. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Kshar basti | (Procedure Reference: Chakradatta,By Dr.Indradev tripathi, choukhambha sanskrit bhavan, Reprint edition 2018,adhyaya 25 Amvata chikitsa ,page no 166,shlok no 1 Vangasena By Hariharprasad tripathi,choukhambha sanskrit bhavan,adhyay ath bastikarmadhikar 90, page no 946 ,shlok no-179. 181, Procedure details: Kshar Basti for first 3 days, Anuvasan Basti on 4th Day then Kshar Basti for last 3 days
Duration for 7 days )
(1) Medicine Name: Pathyadi churna, Reference: Bhayprakash 2nd part,By_ shri Hariharprasadpandeyen adhayay 26 Amvatadhikar,page no -285, shlok no -38, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | Vaitaran Basti | (Procedure Reference: Chakradatta,By Dr.Indradev tripathi, choukhambha sanskrit bhavan,Reprint edition 2018,adhyaya 7 niruhadhikar,page 455,shlok no 32, Procedure details: 300 ml Vaitaran Basti
Duration for 7 days )
(1) Medicine Name: Pathyadi Churna , Reference: Bhayprakash 2nd part,By_ shri Hariharprasadpandeyen adhayay 26 Amvatadhikar,page no -285, shlok no -38, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. subjects having age between 25to55 years
2. Irrespective of gender
3. Patients having symptoms sandhishoola, sandhishotha, sandhistabdhata, sparsha Asahatva, Agnimandya will be selected.
4. known cases of Rheumatoid arthritis
5. RA factor positive patients and also RA factor negative but having signs and symptoms of Amvata.
|
|
| ExclusionCriteria |
| Details |
1. Subjects having known case of HIV,
2. Rheumatic fever with volvular Heart defect.
3. Basti Ayogya.
4. Pregnant women
5. systemic disorder like HTN and uncontrolled DM |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare effects of kshar basti and pathyadi churn orally with vaitaran basti and pathyadi churn orally in Amvata with special refrence to Rheumatoid Arthritis. |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study the efficacy of kshar basti in Amvata.
2. To Study the efficacy of pathyadi Churna in Amvat.
3. To study the efficacy of vaitaran basti in Amvata.
4. To study in detail about Amvata from Ayurvedic texts books.
5. To study in detail about Rheumatoid arthritis from mordern medicine texts |
7 days |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 3 |
|
Date of First Enrollment (India)
|
25/07/2025 |
| 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
|
This is an Randomized open controlled clinical study to evaluate the efficacy between Kshar basti and Pathyadi churn with Vaitaran basti and Pathyadi churna in the management of Amvata w.s.r to Rheumatoid Arthritis.” The assesment of signs and symptoms will be done at regular follow ups. Observation will be drawn from the outcomes achieved in 7 days. |