| CTRI Number |
CTRI/2025/02/080483 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
05/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Panchakarma Procedure (Basti Karma) and Ayurvedic Medicine (Aabhadi Churan) in the management of Gridhrasi w.s.r. to Sciatica. |
|
Scientific Title of Study
|
A Comparative Clinical Study to evaluate the effect of Shampakadi Niruha Basti with and without Aabhadi Churan in the management of Gridhrasi w.s.r. to 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 Abhishek Singh |
| Designation |
MD Scholar |
| Affiliation |
Dayanand Ayurvedic College, Jalandhar |
| Address |
Department of Panchakarma Dayanand Ayurvedic College and Hospital,Mahatma Hans Raj Marg,Jalandhar, Punjab,INDIA
Jalandhar
PUNJAB
144008
India |
| Phone |
7889784428 |
| Fax |
|
| Email |
drabhisheks18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeev Sood |
| Designation |
Professor and HOD of Panchakarma |
| Affiliation |
Dayanand Ayurvedic College, Jalandhar |
| Address |
Department of Panchakarma Dayanand Ayurvedic College and Hospital,Mahatma Hans Raj Marg,Jalandhar, Punjab,INDIA
Jalandhar
PUNJAB
144008
India |
| Phone |
9814004142 |
| Fax |
|
| Email |
drsanjeevsood@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhishek Singh |
| Designation |
MD Scholar |
| Affiliation |
Dayanand Ayurvedic College, Jalandhar |
| Address |
Department of Panchakarma Dayanand Ayurvedic College and Hospital,Mahatma Hans Raj Marg,Jalandhar, Punjab,INDIA
Jalandhar
PUNJAB
144008
India |
| Phone |
7889784428 |
| Fax |
|
| Email |
drabhisheks18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Ayurvedic College and Hospital Jalandhar |
|
|
Primary Sponsor
|
| Name |
Dayanand Ayurvedic College and Hospital Jalandhar |
| Address |
Department of Panchakarma, Dayanand Ayurvedic College and Hospital, Mahatma Hans Raj Marg, Jalandhar, Punjab-144008 INDIA |
| 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 Abhishek Singh |
Dayanand Ayurvedic College, Jalandhar |
Department of Panchakarma Dayanand Ayurvedic College and Hospital,Mahatma Hans Raj Marg,Jalandhar, Punjab,INDIA
Jalandhar
PUNJAB |
7889784428
drabhisheks18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DAC Institutional Ethical Committee |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Aabhadi Churan, Reference: Yog Ratnakar VataVyadhi Chikitsa Page No. 527, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 16 Days, anupAna/sahapAna: Yes(details: Ushna Odaka), Additional Information: Its indicated for curing Gridhrasi | | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Su.Chi.38/43-46, Page No. 566, Bh.Ra.5/1268, Page No. 206,, Procedure details: Basti Karma in kaal yoga will be given to the Gridhrasi Patients i.e. Niruha basti with Shampakadi Kwatha in dose of 480 ml for 6 days & Anuvasana basti with Murchita tila taila in a dose of 80 ml for 10 days.
Poorva Karma:
1.First of all the patient will be subjected to Sathanik Abyanga and Swedan karma on empty stomach. However patient should not be very hungry.
Pradhana Karma:
1.Then for the administration of Basti, the patient will lie on the table in left lateral position with left leg straight and right leg flexed his head should rest on his left flexed arm.
2.Then the anus and Basti netra will be lubricated with oil. Aushadh dravyas (the therapeutic medication) filled in Basti Putaka will be administered through the anal route with the help of the Basti Netra which will be attached to Basti Putaka.
3.The Aushadh dravya will be administered with constant pressure.
4.At last the Basti Netra will be taken out of the anus slowly.
Paschata Karma:
1.Patient will be asked to lie down with his face upward after getting the urge he will eliminate the faeces sitting on his heels.
)
(1) Medicine Name: Shampakadi Niruha Basti, Reference: Su.Chi.38/43-46, Page No. 566, Bh.Ra.5/1268, Page No. 206,, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 480(ml), Frequency: od, Duration: 6 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects having signs and symptoms of Gridhrasi (sciatica).
2.Subjects fit for Basti karma and Swedan karma.
3.Subjects aged between 20 to 70 years of age of either sex.
4.Subjects willing for study.
|
|
| ExclusionCriteria |
| Details |
1.Subjects not fit for Basti karma and Swedan karma.
2.Subjects having any major systemic illness.
3.Subjects not willing for study.
4.Pregnant and lactating women.
5.Fracture of lumbosacral spine.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Significant Improvement in the clinical symptoms of Gridhrasi.
1.Toda (Pricking Sensation)
2.Deha Vakrata (Abnormal Body Posture)
3.Suptata (Numbness)
4.Stambha (Stiffness)
5.Aruchi (Anorexia)
6.Gaurava (Heaviness)
|
Assessment in both the groups will be done:
DAY 16
At the end of the treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Significant Improvement in the objective parameters:
1. SLR Test
2. Flip Test
3. VAS Scale |
Assessment in both the groups will be done:
DAY 16
At the end of the treatment
DAY 30
At the time of follow up |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
18/02/2025 |
| 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="3"
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
|
Gridhrasi(Sciatica) is a common disorder affecting large number of people of both the sex. This disease hinders patient’s daily activities and causes a lot of physical agony to the patient. Despite its high prevalence, there is no lasting relief obtained through NSAID’s, muscle relaxants, corticosteroid injections and surgeries. Whereas Ayurvedic Panchkarma therapies have bright scope in managing Gridhrasi. It is therefore necessary to test and validate a treatment modality for Gridhrasi in order to provide quick and lasting relief. In this study we are evaluating the effect of Shampakdi Niruha Basti with and without Aabhadi Churan in the management of Gridhrasi w.s.r. to Sciatica with the aim of formulating a novel treatment for this disease. |