| CTRI Number |
CTRI/2025/05/086670 [Registered on: 09/05/2025] Trial Registered Prospectively |
| Last Modified On: |
08/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study on the effect of Matravasti with Vajigandhadi taila in Kharapaka and Madhyamapaka in patients with Vataja Gridhrasi |
|
Scientific Title of Study
|
A Comparative Clinical study to evaluate the effect of Matravasti with Vajigandhadi taila in Kharapaka and Madhyamapaka in the management of 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 |
Jemily Thomas |
| Designation |
PG scholar |
| Affiliation |
MVR Ayurveda Medical College |
| Address |
Jemily Thomas
2nd year PG Scholar
Department of Panchakarma
MVR Ayurveda Medical College
Parassinikadavu Kannur
Kannur
KERALA
670563
India |
| Phone |
9074748939 |
| Fax |
|
| Email |
srjemilythomas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shaiju Krishnan P |
| Designation |
MD Ayurveda |
| Affiliation |
MVR Ayurveda Medical College |
| Address |
Dr Shaiju Krishnan P
Head of the Department
Department of Panchakarma
MVR Ayurveda Medical College
Parassinikadavu Kannur
Kannur
KERALA
670563
India |
| Phone |
9400400095 |
| Fax |
|
| Email |
drshaijuvengara@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jemily Thomas |
| Designation |
PG scholar |
| Affiliation |
MVR Ayurveda Medical College |
| Address |
Jemily Thomas
2nd year PG Scholar
Department of Panchakarma
MVR Ayurveda Medical College
Parassinikadavu Kannur
KERALA
670563
India |
| Phone |
9074748939 |
| Fax |
|
| Email |
srjemilythomas@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jemily Thomas |
| Address |
Jemily Thomas
2nd year PG Scholar
Department of Panchakarma
MVR Ayurveda Medical college
Parassinikadavu kannur |
| 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 Jemily Thomas |
MVR Ayurveda Medical College |
Department of Panchakarma
PG studies room
Parassinikadavu
Kannur
KERALA |
9074748939
srjemilythomas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MVR AYURVEDA MEDICAL COLLEGE PARASSINIKADAVU INSTITUTIONAL ETHICAL COMMITTEE |
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 | Procedure | - | mAtrAbastiH, मात्राबस्तिः | (Procedure Reference: Susrutha Samhitha Chikitsastana 35/18, Procedure details: Matravasti with Vajigandhadi taila in Kharapaka for 9 days with 72ml for each patient)
| | 2 | Comparator Arm | Procedure | - | mAtrAbastiH, मात्राबस्तिः | (Procedure Reference: Susrutha Samhitha Chikitsastana 35/18, Procedure details: Matravasti with Vajigandhadi taila in madhyama for 9 days with 72ml for each patient)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants fulfilling the diagnostic criteria
Participants indicating for matravasti |
|
| ExclusionCriteria |
| Details |
Participants with a history of Traumatic injuries
Participants affecting with Lumbar stenosis
Participantts with Vatakaphaja Gridhrasi
Participants containdicated for Matravasti
Pregnant and Lactating Women |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome will be presented in the form of dissertation |
52 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="20"
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)
|
01/06/2025 |
| 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="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
|
To compare the effect of Matravasti with Vajigandhadi taila in Kharapaka and Madhyamapaka with Pharmaceutical analysis in the management of Vataja Gridhrasi To access the samyak,ayoga,atiyoga lakshanas and prathyagamana kala of Matravasti with Vajigandhaditaila in Kharapaka and Madhyamapaka in Vataja Gridhrasi |