| CTRI Number |
CTRI/2026/02/104460 [Registered on: 20/02/2026] Trial Registered Prospectively |
| Last Modified On: |
20/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
A study to find out which of two Ayurvedic oil enema therapies—Erandamooladi Taila or Erandapalindyadi Taila—helps relieve sciatica(Gridrasi) pain better. |
|
Scientific Title of Study
|
A Comparative Clinical Study to evaluate the effectiveness of Anuvasanavasti with Erandamooladi Anuvasana taila and Erandapalindyadi taila in Vataja Gridhrasi. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VANDANA V S |
| Designation |
PG SCHOLAR |
| Affiliation |
MVR AYURVEDA MEDICAL COLLEGE |
| Address |
Department of Panchakarma,
MVR Ayurveda Medical College,
Parassinikadavu,
Kannur,
Kerala
Kannur
KERALA
670563
India |
| Phone |
8921126956 |
| Fax |
|
| Email |
vndnvinodkumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Joshi George |
| Designation |
Guide |
| Affiliation |
MVR AYURVEDA MEDICAL COLLEGE |
| Address |
Department of Panchakarma,
MVR Ayurveda Medical College,
Parassinikadavu,
Kannur,
Kerala
Kannur
KERALA
670563
India |
| Phone |
9400106667 |
| Fax |
|
| Email |
drjoshigeorge@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VANDANA V S |
| Designation |
PG SCHOLAR |
| Affiliation |
MVR AYURVEDA MEDICAL COLLEGE |
| Address |
Department of Panchakarma,
MVR Ayurveda Medical College,
Parassinikadavu,
Kannur,
Kerala
Kannur
KERALA
670563
India |
| Phone |
8921126956 |
| Fax |
|
| Email |
vndnvinodkumar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vandana V S |
| Address |
Department of Panchakarma,
MVR Ayurveda Medical College, PARASSINIKADAVU, Kannur.
pincode-670563 |
| Type of Sponsor |
Other [Self-funding] |
|
|
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 Vandana V S |
MVR Ayurveda Medical College |
Department of Panchakarma,
MVR Ayurveda Medical College, Parassinikadavu,
Kannur.
Pincode-670563
Kannur
KERALA |
8921126956
vndnvinodkumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC MVR AYURVEDA COLLEGE PARASSINIKADAVU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: GRUDHRASI (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Erandamooladi Anuvasana Taila, Reference: vaidyamnorama enna chikitsakramam 24/58, Route: Rectal, Dosage Form: Taila, Dose: 144(ml), Frequency: od, Bhaishajya Kal: Antarabhakta, Duration: 9 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Erandapalindyadi Taila, Reference: Yogamrita, vatavyadhichikitsa/49, Route: Rectal, Dosage Form: Taila, Dose: 144(ml), Frequency: od, Bhaishajya Kal: Antarabhakta, Duration: 9 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
a. Participants satisfying the diagnostic criteria irrespective of gender.
b. Participants within the age group of 18-70 years.
c. Participants fit for Anuvasanavasti karma |
|
| ExclusionCriteria |
| Details |
a. Participants with past history of trauma.
b. Participants with other serious systemic illness – uncontrolled diabetes mellitus, pre diagnosed rheumatoid arthritis.
c. Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of Anuvasanavasti with Erandamooladi anuvasana taila and Erandapalindyadi taila in the management of Vataja Gridhrasi. |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the effectiveness of Anuvasanavasti with Erandamooladi Anuvasanataila in the management of Vataja Gridhrasi.
2. To evaluate the effectiveness of Anuvasanavasti with Erandapalindyadi taila in the management of Vataja Gridhrasi.
3. To assess the Samyak lakshana of Anuvasanavasti. |
18 months |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
16/03/2026 |
| 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
|
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 a randomized, double-blind, parallel-group clinical trial designed to compare the effectiveness of Erandamooladi Anuvasana Taila and Erandapalindyadi Taila administered through Anuvasana Vasti over a period of 9 days in 34 patients. The total study duration is 18 months.
The primary outcome is to compare the effectiveness of Anuvasana Vasti with Erandamooladi Anuvasana Taila and Erandapalindyadi Taila in the management of Vataja Gridhrasi.
The secondary outcomes include:
(1) evaluation of the effectiveness of Anuvasana Vasti with Erandamooladi Anuvasana Taila in Vataja Gridhrasi,
(2) evaluation of the effectiveness of Anuvasana Vasti with Erandapalindyadi Taila in Vataja Gridhrasi, and
(3) assessment of the Samyak Lakshana of Anuvasana Vasti. |