| CTRI Number |
CTRI/2026/02/102887 [Registered on: 03/02/2026] Trial Registered Prospectively |
| Last Modified On: |
20/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Basti ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of APARPINDA TAILAM enema therapy for VATARAKTA-GOUT |
|
Scientific Title of Study
|
RANDOMIZED OPEN CONTROLLED CLINICAL STUDY TO EVALUATE THE
EFFICACY OF APARPINDA TAILAM MATRA BASTI IN VATARAKTA WITH SPECIAL REFERENCE TO GOUT |
| 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 Shravani sunil patil |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic college and post graduate training and research centre,kodoli |
| Address |
Yashwant Ayurvedic college and post graduate training and research centre,panchakarma Department Opd kodoli ,tal -Panhala, Dist-Kolhapur Maharashtra
416114
India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7218432323 |
| Fax |
|
| Email |
Shravnipatil1569@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 and post graduate training and research centre,kodoli |
| Address |
Yashwant Ayurvedic college and post graduate training and research centre,panchakarma Department Opd kodoli ,tal -Panhala, Dist-Kolhapur Maharashtra
416114
India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9822010316 |
| Fax |
|
| Email |
vaidyaravipatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shravani sunil patil |
| Designation |
PG scholar |
| Affiliation |
Yashwant Ayurvedic college and post graduate training and research centre,kodoli |
| Address |
Yashwant Ayurvedic college and post graduate training and research centre,panchakarma Department Opd kodoli ,tal -Panhala, Dist-Kolhapur Maharashtra
416114
India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7218432323 |
| Fax |
|
| Email |
Shravnipatil1569@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic college and post graduate training and research centre, kodoli ,tal -Panhala, Dist-Kolhapur Maharashtra
416114 |
|
|
Primary Sponsor
|
| Name |
Dr Shravani sunil patil |
| Address |
Panchakarma Department OPD (Ground Floor)and IPD Yashwant Ayurvedic college and 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 Shravani sunil patil |
Yashwant Dharmarth Rugnalaya |
Yashwant Ayurvedic college and post graduate training and research centre,panchakarma Department Opd Ground floor,IPD second floor ,kodoli ,tal -Panhala, Dist-Kolhapur Maharashtra 416114 India
Kolhapur
MAHARASHTRA |
7218432323
Shravnipatil1569@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 Tal Panhala Dist Kolhapur Maharashtra India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M109||Gout, 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: Charak chikitsa , Procedure details: Snehan & swedan (Purva karma ) before Basti )
(1) Medicine Name: APARPINDA TAILAM, Reference: Bhavprakash madhyam khanda, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 8 Days | | 2 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Charak chikista, Procedure details: Snehan & swedan (purvakarma) before basti)
(1) Medicine Name: DRAKSHARAS SIDDHA TAILAM, Reference: Chakradutta vatarakta chikitsa 23/35, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 8 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects presenting clinical sign and symptoms specific with Toda shotha Supti Daha Sthabdhata in vatarakta
Serum uric acid range more than 7mg per dl in male
More than 6mg per dl in female
Irrespective of gender and religions
Basti Aarha |
|
| ExclusionCriteria |
| Details |
Subjects with Known case of Amavata Sandhigatavata SLE
Pregnant and Lactating women
menstruating women
Subjects associated with systemic disease like uncontrolled HTN and DM
Chronic renal failure. |
|
|
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 efficacy of Aparpinda Tailam matra basti in Vatarakta
w.s.r Gout. |
8days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To reduce sign and symptoms of vatarakta
2. To assess improvement by sign, symptoms and gradation of
assessment criteria.
3. To study etiopathogenesiss of vatarakta vyadhi indetail from ayurvedic text books.
4. To improve quality of life and reduce discomfort of patient.
5. To evaluate clinically vatarakta with both ayurvedic and allopathy perspective using subjective and Objective parameter.
6. To study karmukta of Aparpinda Tailam Matra Basti in details from classical textbooks. |
8days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
17/02/2026 |
| 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
|
RANDOMIZED OPEN CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF APARPINDA TAILAM MATRA BASTI IN VATARAKTA W.S.R. TO GOUT
The effect of Aparpinda tailam Matra basti will be assessed regards to the clinical sign symptoms on the basis of grade system and overall upshaya.All selected patients for clinical trial will be examined for any changes in their clinical manifestations and feeling of well being,before and after treatment Data will be collected using Case Record Form and will be observed in the form of tables and graph. Results and inferences will be drawn on the basis of data obtained before and after treatment by using appropriate-statistical methods Conclusion will be drawn strictly on the basis of ayurvedic & modern parameters. The results will be discussed on the basis of statistics and the study Will be summarized accordingly. |