| CTRI Number |
CTRI/2025/05/086247 [Registered on: 05/05/2025] Trial Registered Prospectively |
| Last Modified On: |
02/05/2025 |
| 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 trial to study the effect of 2 tailas ,Ashtakatvara taila and Saindhavadya taila in patients with Gridhrasi |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the effect of Katibasti with Ashtakatvara taila and Saindhavadya taila in the management of 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 |
Neena R |
| Designation |
PG scholar |
| Affiliation |
MVR Ayurveda Medical College |
| Address |
Neena R
2nd year PG scholar
Department of Panchakarma
MVR Ayurveda Medical college
Parassinikadavu,Kannur
Kannur
KERALA
670563
India |
| Phone |
9072214989 |
| Fax |
|
| Email |
neenarajendran20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amritha Rajan |
| Designation |
MD Ayurveda PhD |
| Affiliation |
MVR Ayurveda Medical College |
| Address |
Dr Amritha Rajan
Associate professor,
Department of Panchakarma
MVR Ayurveda Medical college
Parassinikadavu,Kannur
Kannur
KERALA
670563
India |
| Phone |
9482414687 |
| Fax |
|
| Email |
dramritharajan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neena R |
| Designation |
PG scholar |
| Affiliation |
MVR Ayurveda Medical College |
| Address |
Neena R
2nd year PG scholar
Department of Panchakarma
MVR Ayurveda Medical college
Parassinikadavu,Kannur
Kannur
KERALA
670563
India |
| Phone |
9072214989 |
| Fax |
|
| Email |
neenarajendran20@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Neena R |
| Address |
Chaitram(H)
Kidangu,LIC Road
perinthalmanna(PO)
Malappuram |
| 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 |
| Neena R |
MVR Ayurveda Medical College |
Department of Panchakarma
PG Studies room
Parassinikadavu
Kannur
KERALA |
9072214989
neenarajendran20@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, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | kaTibastiH, कटिबस्तिः | (Procedure Reference: Ashtanga Hridayam Sutrastana 22/23, Procedure details: katibasti with Saindhavadya taila for 7 days for 45 minutes in each patient))
| | 2 | Intervention Arm | Procedure | - | kaTibastiH, कटिबस्तिः | (Procedure Reference: Ashtanga Hridayam Sutrastana 22/23, Procedure details: katibasti with Ashtakatvara taila for 7 days for 45 minutes in each patient)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants satisfying the diagnostic criteria from both gender
Participants who are sneha and sweda arha
within the age group 20 to 60 years |
|
| ExclusionCriteria |
| Details |
Severe systemic illness that interfere the line of treatment
Participants diagnosed with Carcinoma,Tuberculosis and Traumatic condition of spine
Pregnant and Lactating women
Participants with Uncontrolled Diabetes and Hypertension |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
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
|
Katibasti is a treatment modality which is based on the concept of Murdhini taila. It is a type of Snigdha sweda.The procedure of applying heat to the sacral or lumbar region by retaining warm medicated oil in a frame specially shaped for this area is commonly called katibast..Both these tailas are vatakaphahara in action.By considering the availability of drug,guna karma vishesha this study is designed to compare the effect of Astakatvara taila and Saindhavadya taila in the Management of Gridhrasi
|