| CTRI Number |
CTRI/2024/09/074159 [Registered on: 23/09/2024] Trial Registered Prospectively |
| Last Modified On: |
21/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Vaitrain Basti and Anuvasana Basti With Ashtkatwar Taila in the Management Of Sciatica |
|
Scientific Title of Study
|
A Clinical Study To Evaluate The Efficacy Of Vaitraina Basti and Anuvasana Basti With Ashtkatwar Taila(Kala Basti) in the Management Of Gridhrasi 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 Neeraj Kumar Pathak |
| Designation |
PG Scholar |
| Affiliation |
Post Graduate Institute of Ayurveda Jodhpur Rajasthan |
| Address |
PG Department of Panchkarma Post Graduate Institute of Ayurveda Dr Sarvapalli Radhakrishnan Rajasthan Ayurved University Kadwar Jodhpur Rajasthan India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8959250806 |
| Fax |
|
| Email |
pathakniraj21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gyan Prakash Sharma |
| Designation |
Associate Professor& HOD |
| Affiliation |
Post Graduate Institute of Ayurveda Jodhpur Rajasthan |
| Address |
PG Department of Panchkarma Post Graduate Institute of Ayurveda Dr Sarvapalli Radhakrishnan Rajasthan Ayurved University Kadwar Jodhpur Rajasthan India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9829798701 |
| Fax |
|
| Email |
atreyagyan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gyan Prakash Sharma |
| Designation |
Associate Professor& HOD |
| Affiliation |
Post Graduate Institute of Ayurveda Jodhpur Rajasthan |
| Address |
PG Department of Panchkarma Post Graduate Institute of Ayurveda Dr Sarvapalli Radhakrishnan Rajasthan Ayurved University Kadwar Jodhpur Rajasthan India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9829798701 |
| Fax |
|
| Email |
atreyagyan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute Of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University,Nagaur Road,Kadwad Jodhpur Rajasthan 342037 |
|
|
Primary Sponsor
|
| Name |
Dr Sarvapalli Radhakrishnan Rajasthan Ayurved University Kadwar Jodhpur Rajasthan |
| Address |
Dr Sarvapalli Radhakrishnan Rajasthan Ayurved University Kadwar Jodhpur Rajasthan |
| Type of Sponsor |
Government 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 Neeraj Kumar Pathak |
Ayurveda Hospital Post Graduate Institute Of Ayurved, DSRRAU, Jodhpur |
OPD No. 7, PG department of Panchkarma
Jodhpur
RAJASTHAN |
8959250806
pathakniraj21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE,POST GRADUATE INSTITUTE OF AYURVEDA JODHPUR |
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 | - | anuvAsana-bastiH, अनà¥à¤µà¤¾à¤¸à¤¨-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Chartak chikitsa 27, Procedure details: Poorvakarma- Basti dravya will be prepare as mentioned in the classical text.General & local examination of the patient will be done. The patient will be prepare by local Abhyanga(5-10 minute) & Swedana (3-5 minute). b) Pradhan Karma- The patientwill be asked to lie down comfortably on his/her left side & to keep his head on his/her arm in the form of pillow while keeping the body straight & relaxed left leg. Then the patient will be asked to flex his/her right leg over his/her fully extended left leg. TTjereafter, the anus & the enema nozzle will be lubricated with oil. After removing the air buble, 1/4th of enema nozzle is introduced in the anus slowly without shaking or trembling. c)Pashchat karma - When the administration will over, buttock of the patient will be patted with palm & advised to relax in supine position. The foot end of patient will be raised to the little extent & the pillow will be kept under the head of the patient & soles of the patient will be gently rubbed.)
)
(1) Medicine Name: Asthakatwar tail, Reference: Chartak chikitsa 27, Route: Rectal, Dosage Form: Taila, Dose: 120(ml), Frequency: od, Duration: 16 Days | | 2 | Intervention Arm | Procedure | - | vaitaraNa-bastiH, वैतरण-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: vangsen sanhita, Procedure details: Poorvakarma- Basti dravya will be prepare as mentioned in the classical text.General & local examination of the patient will be done. The patient will be prepare by local Abhyanga(5-10 minute) & Swedana (3-5 minute). b) Pradhan Karma- The patientwill be asked to lie down comfortably on his/her left side & to keep his head on his/her arm in the form of pillow while keeping the body straight & relaxed left leg. Then the patient will be asked to flex his/her right leg over his/her fully extended left leg. TTjereafter, the anus & the enema nozzle will be lubricated with oil. After removing the air buble, 1/4th of enema nozzle is introduced in the anus slowly without shaking or trembling. c)Pashchat karma - When the administration will over, buttock of the patient will be patted with palm & advised to relax in supine position. The foot end of patient will be raised to the little extent & the pillow will be kept under the head of the patient & soles of the patient will be gently rubbed & procedure will be done in Duration: 16 Days)
(1) Medicine Name: vaitarana basti, Reference: vangsen sanhita, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 360(ml), Frequency: od, Duration: 16 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex in the age group of 30 to 60 Years
Clinical signs and symptoms of Gridhrasi present in the classical texts
Tenderness at the course of Sciatica Nerve
Severe pain on squatting
Patients willing to give written consent
|
|
| ExclusionCriteria |
| Details |
Fractured related to spine
Patients who are suffering from any systemic disorders Tuberculosis of spine and Hip Joint Malignancy
Traumatic Infective Neoplastic conditions of Spine
Patients who have lost the control on bladder and defecation
Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of this study is to assess the clinical efficacy of Vaitarana Basti and Ashtkatwar Taila Anuvasana Basti in managing Gridhrasi (Sciatica). It evaluates subjective parameters like pain, stiffness, and pricking pain, along with objective measures such as inflammation markers (ESR, CRP) and imaging tests. |
31 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome aims to enhance the patients quality of life by improving mobility & overall well-being. Additional benefits & any unexpected effects of the treatments will also be monitored. Statistical tests will validate the significance of the treatment outcomes. |
31 days |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/10/2024 |
| 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="1"
Months="0"
Days="0" |
|
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
|
This study is single arm, an open label non randomized trial, with single group of 60 patient to assess the effect of vaitrana basti and Anuvasan basti( with Ashtkatwar Taila) in the management of Gridhrasi( Sciatica). The primary objective of present study is reducing subjective parameters like- Pain, Stiffness ,Pricking pain, Pulsation, Numbness and objective parameters like- Digital X-ray, ESR, CRP. Vaitaran basti and Anuvasan basti (with Ashtkatwar Tail) given in the pattern of Kala Basti ( 16 days). In the present study single group is taken. |