| CTRI Number |
CTRI/2024/10/075025 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
04/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A procedure to study the effect of kolakulattadi upanaha sweda and jaambira pinda sweda in jaanu sandigata vata |
|
Scientific Title of Study
|
A Randomised comparative clinic study to evaluate the efficacy of jaambira pinda sweda and kolakulattadi upanaha sweda in jaanu sandigata vata |
| 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 Rahulgowda |
| Designation |
PG scholar |
| Affiliation |
Shri shivayogeshwara rural ayurvedic medical College and hospital and pg research centre inchal |
| Address |
SSRAMCH PG scholar room department of panchakarma inchal TQ savadatti dst belagavi
Shree shivayogeshwara rural ayurvedic medical College hospital and research centre Inchal
Belgaum
KARNATAKA
591102
India |
| Phone |
9972287895 |
| Fax |
|
| Email |
rahulgowdabiradar333@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G S Hadimani |
| Designation |
Professor |
| Affiliation |
Shri Shivayogeshwara Rural Ayurvedic Medical collage and Hospital inchal |
| Address |
SSRAMCH PG scholar room department of panchakarma inchal TQ savadatti dst belagavi
Shree shivayogeshwara rural ayurvedic medical College hospital and research centre Inchal
Belgaum
KARNATAKA
591102
India |
| Phone |
9632755705 |
| Fax |
|
| Email |
gshadimani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akshay shetty |
| Designation |
Assistant professor |
| Affiliation |
Shri shivayogeshwara rural ayurvedic medical College and hospital inchal |
| Address |
SSRAMCH PG scholar room department of panchakarma inchal TQ savadatti dst belagavi
Shri shivayogeshwara rural ayurvedic medical College hospital and research centre Inchal
Belgaum
KARNATAKA
591102
India |
| Phone |
8892209106 |
| Fax |
|
| Email |
AKSSHETTY402@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| Shri shivayogeshwara rural ayurvedic medical College hospital and research centre inchal 591102 savadatti taluk belgavi district Karnataka |
|
|
Primary Sponsor
|
| Name |
DR Rahulgowda |
| Address |
Shri shivayogeshwara rural ayurvedic medical College hospital and research centre inchal 591102 savadatti taluk belgavi district Karnataka |
| 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 Rahulgowda |
Shri shivayogeshwara rural ayurvedic medical College hospital and research centre Inchal |
inchal tq savadatti dst belagavi panchakarma department room no 35
Belgaum
KARNATAKA |
9972287895
rahulgowdabiradar333@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SSRAMCH Institutional Ethical clearance committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: JANUBEDAHÂ (KEVALAVATA), (2) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | upanAhaH (niragniH), उपनाहः (निरगà¥à¤¨à¤¿à¤ƒ) | (Procedure Reference: Susruta Samhita of Maharsi Susruta with English translation of text and Dalhanas Commentary with critical notes vol -2, Edited and translated by prof Vasant C Pati land DR,Rjeswari N M , Published by Choukhanba publication New Delhi, First edition 2018, Chikitsa Stana,chapter – 4, Verse-4,5,6 , pp 317, Procedure details: Pottalies are put into a pan containing sufficient medicated oil and are heated over mild fire for few min. when they become hot and then taken out and applied over effected part of the knee joint until samyak swinna lakshana.)
| | 2 | Intervention Arm | Procedure | - | piNDasvedaH, पिणà¥à¤¡à¤¸à¥à¤µà¥‡à¤¦à¤ƒ | (Procedure Reference: Keraliya Chikitsa Paddati: A Complete Guide to specialized Kerala Ayurveda Treatment Procedures (Based on Dhara Kalpah), By Dr. Monaj Sankara Narayan and Dr. Pavan Jayaram, Published by Ayurvedic Educational & Charitable Trust, Procedure details: Pottalies are put into a pan containing sufficient medicated oil & are heated over mild fire for few min. when they become hot & then taken out & applied over effected part of the knee joint until samyak swinna lakshana.)
|
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient suffering from Sign and Symptoms of Jaanu Sandigata Vata
Patient is fit for Swedana
Able and willing to
participate and provide signed informed consen
|
|
| ExclusionCriteria |
| Details |
Pregnant women
Unfit for svedana
Lactating women
Patients who are currently participating in an any other clinical trial |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Knee joint pain reduced |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improved day to day activities |
After 14 days of treatment |
|
|
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 3 |
|
Date of First Enrollment (India)
|
20/10/2024 |
| 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="0"
Months="0"
Days="14" |
|
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
|
The trail is for the pg thesis and it is comparative study among the two procedures the title is A Randomised comparative clinical study to evaluate the efficacy of kolakulattadi upanaha sweda and jaambira pinda sweda in management of jaanu sandigata vata.total of 40 patients will be enrolled 20 patients in each group kolakulattadi upanaha sweda in group one and jaambira pinda sweda in group two follow up wil be on 7th day and 14th day.the effect will be noted |