| CTRI Number |
CTRI/2025/02/081152 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Study the effect of Vaishvanar Churna in Amavata with special reference to Rheumatoid Arthritis |
|
Scientific Title of Study
|
Randomised open controlled clinical study to evaluate the efficacy of Vaishvanar Churna in Amavata 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 Akash Patil |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic College and Post Graduate Training and Research Centre Kodoli |
| Address |
OPD No 17 kayachikitsa Department Second Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli
Tal Panhala Dist Kolhapur MAHARASHTRA
416114 India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9834523498 |
| Fax |
|
| Email |
akkippatil558@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suryakiran Parshuram Wagh |
| Designation |
HOD Kayachikitsa Department |
| Affiliation |
Yashwant Ayurvedic College and Post Graduate Training and Research Centre Kodoli |
| Address |
OPD No 17 kayachikitsa Department Second Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli
Tal Panhala Dist Kolhapur MAHARASHTRA
416114 India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9822846910 |
| Fax |
|
| Email |
Suryakiran_wagh@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akash Patil |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic College and Post Graduate Training and Research Centre Kodoli |
| Address |
OPD No 17 kayachikitsa Department Second Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli
Tal Panhala Dist Kolhapur MAHARASHTRA
416114 India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9834523498 |
| Fax |
|
| Email |
akkippatil558@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic College and Post Graduate Training and
Research Centre Kodoli Kolhapur Maharashtra 416114 |
|
|
Primary Sponsor
|
| Name |
Dr Akash Patil |
| Address |
OPD No 17 kayachikitsa Department Second Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli
Tal Panhala Dist Kolhapur MAHARASHTRA
416114 India |
| 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 Akash Patil |
Yashwant Dharmartha Rugnalaya |
OPD No 17 kayachikitsa Department Second Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli
Tal Panhala Dist Kolhapur MAHARASHTRA
416114 India
Kolhapur
MAHARASHTRA |
9834523498
akkippatil558@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Yashwant Ayurvedic College PGT and RC kodoli |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Chitrakadi Churna , Reference: Bhavprakash Madhyam Khanda Shlok-45, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Koshna Jala), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vaishvanar Churna , Reference: Bhavaprakash Madhyam Khanda Shlok 71-74, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Koshna Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects of age between 18-65 years.
2. Irrespective of Gender.
3. Sandhishool
4. Sandhishoth
5. R.A Factor positive patient |
|
| ExclusionCriteria |
| Details |
1. Pregnant women and lactating mothers
2. Vatarakta
3. Rheumatic fever, Rheumatic Heart disease
4. Known case of heart disease, amavata upadravas
5. Patients of known history of hypertension, HIV or diabetes |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of vaishvanar churna in Amavata W.S.R. to Rheumatoid arthritis. |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study the disease Amavata and Rheumatoid Arthritis in
detail.
2. To study the efficacy of Vaishvanar Churna as per
mentioned in ayurved samhita.
3. To study the effect of vaishvanar Churna for signs sandhi
shoola and Sandhi shotha in 28 days of duration.
4. To study the modern aspect of Rheumatoid Arthritis.
5. To study the efficacy of Chitrakadi churna in amavata. |
28 days |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/03/2025 |
| 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 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
|
Randomised open Controlled clinical trial to evaluate the efficacy of Vaishvanar Churna in Amavata w s r to Rheumatoid Arthritis Assessment of Signs and Symptoms will be done on regular intervals Outcome will assess after 28days |