| CTRI Number |
CTRI/2024/10/075852 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of yogottama gutika and gokshura taila Matra vasti in the management of Kati graha -Inter Vertebral Disc Prolapse |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY ON THE EFFICACY OF YOGOTTAMA GUTIKA(ORALLY) WITH OR WITHOUT GOKSHURA TAILA MATRA VASTI IN THE MANAGEMENT OF KATI GRAHA W.S.R TO INTER VERTEBRAL DISC PROLAPSE
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Baliga Ashok Kumar |
| Designation |
Post graduate Department of Kaya chikitsa |
| Affiliation |
Dr Brkr government ayurvedic college |
| Address |
Beside Central Bank,mantada, Pamidimukkala mandal, Krishna district, AP
Opposite ESI hospital, erragadda, Hyderabad, Telangana
Hyderabad
TELANGANA
521256
India |
| Phone |
9866735326 |
| Fax |
|
| Email |
ashokbaliga123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Aruna gayatri |
| Designation |
Professor,Department of kayachikitsa |
| Affiliation |
Dr Brkr government ayurvedic college |
| Address |
Dr Brkr government ayurvedic college ,Department of kayachikitsa, Division 2 op no-2,erragadda hyderabad telangana
Opposite ESI hospital, erragadda, Hyderabad, Telangana
Hyderabad
TELANGANA
500038
India |
| Phone |
9490285547 |
| Fax |
|
| Email |
ketharajugayathri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Baliga Ashok Kumar |
| Designation |
Post graduate Department of Kaya chikitsa |
| Affiliation |
Dr Brkr government ayurvedic college |
| Address |
Dr Brkr government ayurvedic college , division 2 op no 2, Hyderabad Telangana
Opposite ESI hospital, erragadda, Hyderabad, Telangana
Hyderabad
TELANGANA
500038
India |
| Phone |
9866735326 |
| Fax |
|
| Email |
ashokbaliga123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Brkr government ayurvedic college and hospital erragadda Hyderabad Telangana India |
|
|
Primary Sponsor
|
| Name |
Dr Baliga Ashok Kumar |
| Address |
Dr Brkr government ayurvedic college and hospital Opposite ESI hospital, erragadda Hyderabad Hyderabad Telangana-500038 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| B Ashok Kumar |
Dr Brkr government ayurvedic college |
Department of Kaya chikitsa, OPD 2, Room no 2
Hyderabad
TELANGANA |
9866735326
ashokbaliga123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee approval letter |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M512||Other thoracic, thoracolumbar andlumbosacral intervertebral disc displacement. Ayurveda Condition: ASTHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Yogottama gutika , Reference: Gada nigraha , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -jala), Additional Information: - | | 2 | Comparator Arm | Procedure | - | Matra vasti | (Procedure Reference: Ashtanga hridaya , Procedure details: Gokshura taila-60ml Rectally for 7days for 2 sittings )
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient who are presenting with signs and symptoms of Kati Graha
2 Patients who are diagnosed with Inter-vertebral disc prolapse.
3 Patients who are willing to participate in study and who signed the
consent from.
4 Patients who can come for review and follow up regularly. |
|
| ExclusionCriteria |
| Details |
1 Patients who are contraindicated for Vasti karma.
2 H/O hypersensitivity to the trail drug or any of its ingredients.
3 Patients having infective conditions of spine like T.B of spine etc.
4 Patients having chronic ankylosing spondylosis, spinabifida.
5 Patients having abhigatajanya Kati graha.
6 Patients with evidence of malignancy.
7 Patients with uncontrolled Diabetes mellitus and uncontrolled Hypertension.
8 Patients with unstable Cardio vascular disease.
9 Patients suffering from other major systemic illness necessitating long term drug treatment.
10Patients with concurrent serious hepatic disorder or Renal disorder.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To assess the efficacy of Yogottama Gutika(orally) and Gokshura taila Matra Vasti in the management of Kati Graha w.s.r. to Inter-Vertebral disc prolapse[I V D P]. |
6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To provide comprehensive, effective care in Kati Graha.
2. To enhance the quality of life in Kati Graha patients.
3. Detailedstudy of the disease covering classicaland modern literature |
6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/11/2024 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ashokbaliga123@gmail.com].
- For how long will this data be available start date provided 02-10-2024 and end date provided 02-10-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
Brief Summary
Modification(s)
|
Study design: open labelled COMPARATIVE clinical trail
Number of groups: TWO [Group- A and Group- B]
- In the present study, it has been proposed to include 40 patients of diagnosed with Kati Graha between the age group of 20 - 60 years, selected and placed in two groups A and B pertaning to the therapy schedule. - 20 patients of group A will be treated with Yogottama Gutika (orally) only and 20 patients of group B will be treated with Drug Yogottama Gutika (orally) along with Gokshura taila Matra Vasti(internally). |