| CTRI Number |
CTRI/2025/08/093835 [Registered on: 28/08/2025] Trial Registered Prospectively |
| Last Modified On: |
17/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two methods of Vaitharana Vasti for People Suffering from Sciatica |
|
Scientific Title of Study
|
Optimizing Vaitharana Vasti Therapy-A Clinical study to assess the comparative outcomes of two regimens of Vaitharana Vasti- with and without Matra Vasti in the treatment of Gridhrasi WSR 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 |
Adarsh E K |
| Designation |
Phd scholar |
| Affiliation |
Glocal college of ayurvedic medical sciences and research center |
| Address |
Glocal college of Ayurvedic medical science and research Center
Department of Panchakarma, Room 2
Saharanpur
UP Dept of Panchakarma
Room no 2 Saharanpur UTTAR PRADESH 247121 India |
| Phone |
9961556113 |
| Fax |
|
| Email |
dradarshek@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Dr P J George |
| Designation |
Professor and Guide |
| Affiliation |
Glocal college of Ayurvedic medical science and research Center |
| Address |
Glocal college of Ayurvedic medical science and research Center
Department of Panchakarma, Room 2
Saharanpur
UP
Saharanpur UTTAR PRADESH 247121 India |
| Phone |
9846618254 |
| Fax |
|
| Email |
georgepoothavelil@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Adarsh E K |
| Designation |
Phd scholar |
| Affiliation |
Glocal college of ayurvedic medical sciences and research center |
| Address |
Glocal college of Ayurvedic medical science and research Center
Department of Panchakarma, Room 2
Saharanpur
UP
Saharanpur UTTAR PRADESH 247121 India |
| Phone |
9961556113 |
| Fax |
|
| Email |
dradarshek@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Adarsh E K |
| Address |
Phd scholar
Glocal college of Ayurvedic medical science and research Centre
Saharanpur
UP - 247121
India |
| 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 Anupam Singh |
Mahaveer Ayurveda Medical College |
Department of Panchakarma, Room No 2
Pohalli
Sardanar Road
Meerut Meerut UTTAR PRADESH |
8279401470
dranupamsingh78@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Mahaveer Ayurvedic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G00-G99||Diseases of the nervous system. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | vaitaraNa-bastiH, वैतरण-बस्तिः | (Procedure Reference: Vangasena Samhita or Chiktsasara samhita of Vangasena, Vasti Adhikara by Dr Nirmal Saxena, Chaukhambha Sanskrit Series, Page No. 291, Procedure details: Vaitaranavasti given to the patients for 8 days (Every Day)
Vaitarana Vasti ingredients
Saindhava Lavana - 12 gm
Guda - 24 gm
Chincha - 48 gm
Sneha (Sahacharadi tailam) - 96 ml
Godugdha - 192 ml)
| | 2 | Comparator Arm | Procedure | - | yoga-bastiH, योग-बस्तिः | (Procedure Reference: Vangasena Samhita or Chikitsasara Samhita of Vangasena by Dr Nirmal Saxena, Chaukhabha Sanskrit Series, Vasti Adhikara, Page. 291, Procedure details: Vaitaranavasti given as Yogavasti.
Day 1 - Matravasti (Sahacharadi tailam 60ml)
Day 2 - Vaitarana Vasti
Day 3 - Matravasti (Sahacharadi tailam 60ml)
Day 4 - Vaitarana Vasti
Day 5 - Matravasti (Sahacharadi tailam 60ml)
Day 6 - Vaitarana Vasti
Day 7 - Matravasti (Sahacharadi tailam 60ml)
Day 8 - Matravasti (Sahacharadi tailam 60ml))
|
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient having clinical features of Gridhrasi both vataja and vatakaphaja
2 Radiological changes, degenerative changes in lumbar spine
3 Low back pain more than 3 months
4 Patient who are Vasti yoga |
|
| ExclusionCriteria |
| Details |
1 Patient associated with systemic disorders
2 Patient with uncontrolled hypertension
3 Patient with trauma in Lumbar spine
4 Patient wit Carcinoma of spine
5 Patient with congenital deformity of vertebral column
6 Patient contraindicated to Vasti
7 Pregnant women and lactating mother
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
SLRT
Walking time
Visual analogue scale |
Day 0
Day 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual analogue scale |
Day 24 |
|
|
Target Sample Size
|
Total Sample Size="130" Sample Size from India="130"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/09/2025 |
| 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="0" 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
|
The management of Vata-related disorders in Ayurveda often employs various therapeutic interventions, with Vasti therapy being one of the most prominent. Vaitharana Vasti, is traditionally used to address conditions associated with Vata dosha imbalances, like Sciatica. Matra Vasti, which incorporates additional oil or medicated substances, is believed to enhance the therapeutic effects of the treatment by facilitating deeper absorption and providing additional nourishment to the affected tissues. Despite the widespread use of both Vaitharana and Matra Vasti in clinical practice, there is limited empirical evidence comparing their efficacy. This lack ofcomparative studies raises critical questions regarding the optimal therapeutic approach for managing Vata disorders. Specifically, the research problem is centered on determining whether the addition of Matra Vasti significantly enhances the clinical outcomes of Vaitharana Vasti. Clarifying the comparative effectiveness of these two treatment approaches can guide practitioners in optimizing therapeutic strategies for better patient outcomes.
This study will be a randomized open clinical trial with pre and post-test design. Having 2 trial groups, patients are randomly allocated to each group forevaluation irrespective of sex, caste, religion and socio-economic status if the inclusion and exclusion criteria meets.
Group 1-Vaitharana Vasti daily for 8 days Group 2- Vaithrana Vasti in Yoga Vasti schedule for 8 days |