| CTRI Number |
CTRI/2025/09/095002 [Registered on: 17/09/2025] Trial Registered Prospectively |
| Last Modified On: |
17/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study of ayurvedic procedure kshara basti and ayurvedic drug alambushadi churna on amavata |
|
Scientific Title of Study
|
Clinical evaluation of kshara basti and alambushadi churna on amavata |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRIYANKA SARKAR |
| Designation |
PG SCHOLAR |
| Affiliation |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR |
| Address |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR DELHI HIGHWAY UTTARAKHAND
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR DELHI HIGHWAY UTTARAKHAND
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8630553552 |
| Fax |
|
| Email |
pinki7228@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikram Gupta |
| Designation |
PROFESSOR |
| Affiliation |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR |
| Address |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR DELHI HIGHWAY UTTARAKHAND
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR DELHI HIGHWAY UTTARAKHAND
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8958640973 |
| Fax |
|
| Email |
vdvikram20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikram Gupta |
| Designation |
PROFESSOR |
| Affiliation |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR |
| Address |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR DELHI HIGHWAY UTTARAKHAND
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR DELHI HIGHWAY UTTARAKHAND
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8958640973 |
| Fax |
|
| Email |
vdvikram20@gmail.com |
|
|
Source of Monetary or Material Support
|
| PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR DELHI HIGHWAY UTTARAKHAND PIN 249405 |
|
|
Primary Sponsor
|
| Name |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR |
| Address |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR DELHI HIGHWAY UTTARAKHAND |
| Type of Sponsor |
Private medical college |
|
|
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 PRIYANKA SARKAR |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN |
DEPARTMENT OF KAYACHIKITSA OPD NO 13/14, DEPARTMENT OF PANCHKARMA OPD NO 4, PATANJALI AYURVED HOSPITAL, PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN, PHASE 1 HARIDWAR DELHI HIGHWAY, 249405 UTTARAKHAND
Hardwar
UTTARANCHAL |
08630553552
pinki7228@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN, HARIDWAR, UTTARAKHAND |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M959||Acquired deformity of musculoskeletal system, unspecified. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Chakrapanidutta, Chakradutta Amavata chikitsa -1, Procedure details: PURVA KARMA- Deepana-Pachana will be done by giving Shunthi siddha Jala (1-2 gms shunthi churna infused in 250 ml hot water) twice a day 30 minutes before meal for 3 days
PRADHANA KARMA- Individual will be asked to lie downcomfortably on his/her left side to keep head on his arms in the form of pillow while keeping the body straight and relaxed, then the individual will be asked to flex his right leg over his fully extended left leg. thereafter anus and enema nozzle will be lubricated with oil. after removing air bubble, appropriate quantity of prepared Kshara basti (500ml) will be administered.basti will be given in Modified Kala Basti schedule (9 Anuvasana, 6 Kshara basti).
Anuvasana basti (70ml) will be given with Saindhavadi Taila,
Paschata karma- individual will be advised to lie on his back i.e. supine position comfortablyon the bed. individual willbe advised to empty his bowel after getting urge for defecation)
(1) Medicine Name: Kshara Basti, Reference: Chakrapanidutta, Chakradutta, Niruhadhikara, 29-31, Route: Rectal, Dosage Form: Not Applicable, Dose: 500(ml), Frequency: od, Duration: 9 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Alambushadi churna, Reference: Chakrapanidutta Chakradutta, Amavata chikitsa prakaran, 41-43, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -ushna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of Amavata with features of Rheumatoid Arthritis as specified in 2010 ACR- EULAR classification
Age- 18- 65 years, irrespective of gender, caste, religion, etc
Patients who are fit for BASTI KARMA as described in Charak Siddhi sthana
|
|
| ExclusionCriteria |
| Details |
Patient with history of Impaired cardiac, renal, hepatic disorders
Known inherited genetic syndrome
Patients with known history of any direct or indirect trauma on joints
Pregnancy and / or lactating mother
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| RA factor, ESR, CRP |
0 day, 30 day, 60 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
joint pain
tenderness around the joints
joint swelling
stiffness
heat over the affected joints
|
0 day, 30 day, 60 day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
29/09/2025 |
| 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 open-label, single arm clinical trial will evaluate the efficacy and safety of Kshara Basti followed by Alambushadi Churna in patients of Amavata (Rheumatoid Arthritis). 40 patients fulfilling ACR/EULAR 2010 criteria will be enrolled from OPD/IPD of Kayachikitsa/ Panchkarma, Patanjali Ayurvigyan Evam Anusandhan Sansthan, Haridwar. The intervention aims to provide safe and effective Ayurvedic management of Amavata.
|