| CTRI Number |
CTRI/2024/05/067663 [Registered on: 20/05/2024] Trial Registered Prospectively |
| Last Modified On: |
17/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study On Agnikarma(Cauterisation) Followed By Vaitarana Basti(Medicated enema) in Gridhrasi(Sciatica) |
|
Scientific Title of Study
|
A Clinical Study On Agnikarma Followed By Vaitarana Basti in Gridhrasi vis-a-vis Sciatica |
| 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 Surabhi Srihari Vasisht |
| Designation |
Postgraduate Scholar |
| Affiliation |
Sri kalabyraveshwaraswamy ayurvedic medical college, Hospital and research centre |
| Address |
3rd Floor, Department of PG Studies in Panchakarma
Sri Kalabyraveshwara Swamy Ayurvedic Medical College, Hospital and Research centre
Sri Kalabyraveshwara Swamy Ayurvedic Medical College, Hospital and Research centre No10 Pipeline Road R.P.C. Layout Vijayanagar Bangalore-560104
Bangalore
KARNATAKA
560104
India |
| Phone |
9972125991 |
| Fax |
|
| Email |
surabhi.srivasisht09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Supreeth M J |
| Designation |
Associate Professor |
| Affiliation |
Sri kalabyraveshwaraswamy ayurvedic medical college, Hospital and research centre |
| Address |
3rd Floor, Department of PG Studies in Panchakarma
Sri Kalabyraveshwara Swamy Ayurvedic Medical College, Hospital and Research centre
Sri Kalabyraveshwara Swamy Ayurvedic Medical College, Hospital and Research centre
No10 Pipeline Road R.P.C. Layout Vijayanagar Bangalore-560104
Bangalore
KARNATAKA
560104
India |
| Phone |
9742918461 |
| Fax |
|
| Email |
supreethmj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Supreeth M J |
| Designation |
Associate Professor |
| Affiliation |
Sri kalabyraveshwaraswamy ayurvedic medical college, Hospital and research centre |
| Address |
3rd Floor, Department of PG Studies in Panchakarma
Sri Kalabyraveshwara Swamy Ayurvedic Medical College, Hospital and Research centre
Sri Kalabyraveshwara Swamy Ayurvedic Medical College, Hospital and Research centre
No10 Pipeline Road R.P.C. Layout Vijayanagar Bangalore-560104
Bangalore
KARNATAKA
560104
India |
| Phone |
9742918461 |
| Fax |
|
| Email |
supreethmj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self Funded Trial
Sri Kalabyraveshwara Swamy Ayurvedic Medical College, Hospital and Research centre
Vijayanagar, Bangalore |
|
|
Primary Sponsor
|
| Name |
Dr Surabhi Srihari Vasisht |
| Address |
No10 Pipeline Road R.P.C. Layout Vijayanagar Bangalore-560104
|
| Type of Sponsor |
Other [Self Funded ] |
|
|
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 Kiran M Goud |
Sri kalabyraveshwaraswamy ayurvedic medical college, Hospital and research centre |
3rd Floor, Department of PG Studies in Panchakarma
Sri Kalabyraveshwara Swamy Ayurvedic Medical College, Hospital and Research centre
No10 Pipeline Road R.P.C. Layout Vijayanagar Bangalore-560104
Bangalore
KARNATAKA |
9845109556
kiranmgoud@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKAMCH&RC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M543||Sciatica. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: sushruta sutra 12, Procedure details: Snigdha agnikarma with dhatura patra on the most tender points of sciatic nerve on the first day of the intervention.)
| | 2 | Intervention Arm | Procedure | - | vaita | (Procedure Reference: chakradatta niruhadhikara 32, Procedure details: vaitarana basti in the dosage form mentioned by chakradatta in yoga basti pattern for 8 days with 3 niruha and 5 anuvasana)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects of either gender in between the age group of 18-70 years.
Subjects presenting with Lakshanas of Gridhrasi.
Subjects presenting with clinical features of Sciatica.
Subjects fit for Agnikarma and Basti karma
|
|
| ExclusionCriteria |
| Details |
Subjects with any systemic disease which may interfere with the course of treatment. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of subjective parameter like ruk, Toda, stambha, muhu spandana, gourava, aruchi, tandra
objective parameter is SLR, bragards test and bowstring test. |
Assessment before the treatment,on the first day after agnikarma and on 9th day after completion of basti |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
Not Applicable |
|
|
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 |
|
Date of First Enrollment (India)
|
30/05/2024 |
| 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
|
Not Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Gridhrasi is a Ruja pradhana vyadhi showing symptoms like Ruk, Toda, Stambha and Muhur Muhur Spandana in the Sphik, Kati, Uru, Janu, Jangha and Pada in a chronological order along with Sakthi Utkshepanigraha and Dehasya pravakrata resembling the gait of a vulture where the specific treatment in the classics includes siravyadha, agnikarma and basti karma. Thus, in this study an attempt is made to see the combined effect of both Agnikarma and Vaitarana basti in relieving the symptoms of Gridhrasi vis-a-vis Sciatica.
|