| CTRI Number |
CTRI/2024/11/076125 [Registered on: 01/11/2024] Trial Registered Prospectively |
| Last Modified On: |
25/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To see effect of Vishnu taila matra basti in managing Vatarakta |
|
Scientific Title of Study
|
Clinical study to evaluate efficacy of vishnu taila (swalpam) matra basti in the management of 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 |
Vd Mayuri Anil Sonkamble |
| Designation |
MD Scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya, pune |
| Address |
Tilak Ayurved Mahavidyalaya, Department of Panchakarma, Rasta peth Pune
Tarachand Ramnath Charitable Ayurvedic Hospital, Ratsa Peth, Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9423495463 |
| Fax |
|
| Email |
mayurisonkamble164@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Rahul Surendra Kathawate |
| Designation |
Associate Professor Department of Panchakarma |
| Affiliation |
Tilak Ayurved Mahavidyalaya, pune |
| Address |
Tilak Ayurved Mahavidyalaya, Department of Panchakarma, Rasta peth Pune
Tarachand Ramnath Charitable Ayurvedic Hospital, Ratsa Peth, Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
7385201786 |
| Fax |
|
| Email |
vdrahulkathawate@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Mayuri Anil Sonkamble |
| Designation |
MD Scholar |
| Affiliation |
Tilak ayurved mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya, Department of Panchakarma, Rasta peth Pune
OPD no 12, department of panchakarma, first floor rasta peth pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9423495463 |
| Fax |
|
| Email |
mayurisonkamble164@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak ayurved mahavidyalaya & seth tarachand ramnath charitable ayurvedic hospital rasta peth pune 411011 |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalaya Pune |
| Address |
Rasta Peth Pune 411011 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Mayuri Anil Sonkamble |
Tilak ayurved Mahavidyalaya and Seth tarachand ramnath charitable hospital rasta peth pune |
OPD no 12, department of panchakarma, first floor rasta peth pune
Pune
MAHARASHTRA |
9423495463
mayurisonkamble164@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tilak ayurved Mahavidyalaya and Seth tarachand ramnath charitable ayurvedic hospital Institutional Ethics Committee |
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, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Ashtang hruday Sutrasthana 19/68-69, Procedure details: is a procedure in which medicated oil is administered through anal route. it can be given at anytime . since the dosage of sneha used in matra basti is very low, there will be no fear of any complication. basti can be given upto 15 days )
(1) Medicine Name: Vishnu Taila (swalpam), Reference: Bhaishajya Ratnavali vatavyadhi chikitsa 115-122, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient with age group 25-65 yrs og either gender.
2.Patient having minimum 3 signs and symptoms of Vatarakta i.e ruka, toda, sparshasahatva, kandu, daha, twak vaivarnya, shotha, stambha.
|
|
| ExclusionCriteria |
| Details |
1.Participants who are contraindicated for basti as per brihatrayi.
2.Known history of Chronic systemic diseases like Rheumatoid arthritis, Osteoarthritis, Diabetes, Renal and Hepatic diseases.
3.known history of HIV , HbsAg positive patient .
4.Participants taking medication like corticosteroid, local application containing steroid , analgesic, self medication will be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate efficacy of Vishnu taila matra basti in the management of Vatarakta |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decreased in symptoms like ruka, toda, sparshasahatva, kandu, daha, twak vaivarnya, shota, stambha |
30 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
05/11/2024 |
| 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
|
Number of patients suffering with Vatarakta is becoming quite high. The modern science is mainly based on symptomatic treatment which includes analgesics and physiotherapy. Surgery is another option but is economically not possible to every patient. In ayurvedic samhitas there are many better options available for treatment of Vatarakta. Vatarakta is one of the vaatvyadhi and basti being ardha chikitsa of vaatvyadhi, it will also be effective in this condition. Hence a clinical study to evaluate efficacy of Vishnu taila (swalpam) matra basti in management of Vatarakta and the observations will be drawn from the outcome of patients. |