| CTRI Number |
CTRI/2025/07/092026 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
29/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
An Exploratory study to assess the understanding and application of the concept of Gulma among Ayurvedic physicians in Kerala |
|
Scientific Title of Study
|
An Exploratory study to assess the understanding and application of the concept of Gulma among Ayurvedic physicians in Kerala |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
GOPIKA NATARAJ |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVERNMENT AYURVEDA COLLEGE KANNUR |
| Address |
Dept of Roganidana
GOVERNMENT AYURVEDA COLLEGE PARIYARAM KANNUR
Dept of Roganidana
GOVERNMENT AYURVEDA COLLEGE PARIYARAM KANNUR
Kannur
KERALA
670503
India |
| Phone |
7907518248 |
| Fax |
|
| Email |
gopikanataraj9758@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Babita Radhakrishnan |
| Designation |
Asst Professor |
| Affiliation |
GOVERNMENT AYURVEDA COLLEGE KANNUR |
| Address |
Department of Roganidana
GOVERNMENT AYURVEDA COLLEGE PARIYARAM KANNUR
Department of Roganidana
GOVERNMENT AYURVEDA COLLEGE PARIYARAM KANNUR
Kannur
KERALA
670503
India |
| Phone |
9895128253 |
| Fax |
|
| Email |
drbabirkrishnan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
GOPIKA NATARAJ |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVERNMENT AYURVEDA COLLEGE KANNUR |
| Address |
Dept of Roganidana
GOVERNMENT AYURVEDA COLLEGE PARIYARAM KANNUR
Dept of Roganidana
GOVERNMENT AYURVEDA COLLEGE PARIYARAM KANNUR
Kannur
KERALA
670503
India |
| Phone |
7907518248 |
| Fax |
|
| Email |
gopikanataraj9758@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt ayurveda college pariyaram kannur 670503 |
|
|
Primary Sponsor
|
| Name |
GOVERNMENT AYURVEDA COLLEGE KANNUR |
| Address |
GOVERNMENT AYURVEDA COLLEGE PARIYARAM KANNUR |
| Type of Sponsor |
Government medical college |
|
|
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 GOPIKA NATARAJ |
GOVERNMENT AYURVEDA COLLEGE HOSPITAL KANNUR |
Dept of Roganidana
Room 7
GOVERNMENT AYURVEDA COLLEGE PARIYARAM KANNUR
Kannur
KERALA |
7907518248
gopikanataraj9758@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GOVERNMENT AYURVEDA COLLEGE KANNUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
FOCUS GROUP DISCUSSION WITH EXPERTS |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
as it is a descriptive study there is no inclusion criteria |
|
| ExclusionCriteria |
| Details |
as it is a descriptive study there is no exclusion criteria |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Understanding and application of gulma |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Questionnaire will be analysed for assessing the outcome. The concept of gulna will be understood in a better way & information s will be made useful for all practicing Ayurveda |
18months |
|
|
Target Sample Size
|
Total Sample Size="167"
Sample Size from India="167"
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)
|
25/09/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 study titled *“An Exploratory Study to Assess the Understanding and Application of the Concept of Gulma Among Ayurvedic Physicians in Kerala”* aims to explore the diagnostic methods and therapeutic interventions related to Gulma within the Ayurvedic framework using a Knowledge, Attitude, and Practices (KAP) survey. Ayurvedic physicians, with their expertise and therapeutic knowledge, play a crucial role in clarifying the concept of Gulma. The study will begin by collecting and reviewing relevant literature on Gulma, followed by in-depth interviews and Focus Group Discussions (FGDs) conducted until saturation is achieved. Based on the insights gained, a questionnaire will be developed. Data will be gathered through direct or telephonic interviews with Ayurvedic physicians. The responses will be analyzed to assess the outcomes and understanding of Gulma within the Ayurvedic community. |