| CTRI Number |
CTRI/2025/03/082573 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of Effect of Basti Treatment in Joint Disorders (Autoimmune Disease) |
|
Scientific Title of Study
|
Exploration of Karma Siddhant with special reference to Effect of Yashtyahva Basti in Vatarakta |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Alka yadav |
| Designation |
M D Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Siddhant Darshan
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7054938646 |
| Fax |
|
| Email |
alkayadav0011@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Rani Singh |
| Designation |
HOD & Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Siddhant Darshan
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8601095944 |
| Fax |
|
| Email |
rani@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Prof Rani Singh |
| Designation |
HOD & Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Siddhant Darshan
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8601095944 |
| Fax |
|
| Email |
rani@bhu.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of Siddhant Darshan
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Varanasi 221005
Uttar Pradesh
India
|
|
|
Primary Sponsor
|
| Name |
Dr Alka yadav |
| Address |
Department of Siddhant Darshan
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Varanasi 221005
Uttar Pradesh
India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Panchakarma |
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Varanasi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Alka yadav |
Department of Panchakarma |
Sir Sundar Lal Hospital
Room no 16C
Department of Panchakarma
Institute of Medical Sciences
Banaras Hindu University
Varanasi 221005
Varanasi
UTTAR PRADESH |
7054938646
alkayadav0011@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IMS BHU Institutional Ethics 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: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Charaka Samhita Siddhisthana 3/46, Procedure details: The patient is advised to lie down in left lateral position apply little quantity of oil on patient anus & Bastinetra for lubrication The Bastinetra is gently inserted into the anal canal up to a one fourth part of Bastinetra & Bastiputaka containing mixture is pressed with a uniform pressure.)
|
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Sign and Symptoms of Vatarakta patients complaining of Kandu Daha Ruja Akunchanprasaranvedana Sandhisotha Stabdhtata Mandalouttpati etc (any 4 symptoms are present )
Basti Karma Yogya |
|
| ExclusionCriteria |
| Details |
Basti Karma Ayogya Patients
Patient with the symptoms Asadhya Vatarakta (Unconsciousness etc)
Patient who are not willing to give consent |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of Yashtyahva Basti in Vatarakta with respect to subjective symptoms |
Basti Karma for 7 days and will be assessed after 14 days so a total of 21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of Yashtyahva Basti in Vatarakta with respect to biochemical tests |
21 days |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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 |
|
Date of First Enrollment (India)
|
03/04/2025 |
| 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="0"
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
|
Exploration of Karma Siddhant with special reference to effect of Yashtyahva Basti in Vatarakta in either gender patients between the age group of 16-70 years. |