| CTRI Number |
CTRI/2025/12/099444 [Registered on: 18/12/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of Ayurvedic Diagnostic Criteria (Nidana Panchaka) in Patients with Grahani (Digestive Disorders) A Cross-Sectional Study. |
|
Scientific Title of Study
|
A cross-sectional study on the application of nidana panchaka of grahani:with special reference to gastrointestinal disorders |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjali Vaishnav |
| Designation |
MD SCHOLAR |
| Affiliation |
National Institute of Ayurveda Jaipur (Raj.) |
| Address |
DEPARTMENT OF ROGA NIDANA EVAM VIKRITI VIGYANA
National Institute of Ayurveda Deemed To Be University (De-novo) Jorawar Singh
Gate Amer Road Jaipur (Raj.)
Jaipur
RAJASTHAN
302002
India |
| Phone |
8696798497 |
| Fax |
|
| Email |
anjalivaishnav632@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrPreeti Gavali |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Ayurveda Jaipur (Raj.) |
| Address |
DEPARTMENT OF ROGA NIDANA EVAM VIKRITI VIGYANA
National Institute of Ayurveda Deemed To Be University (De-novo) Jorawar Singh
Gate Amer Road Jaipur (Raj.)
Jaipur
RAJASTHAN
302002
India |
| Phone |
8851832017 |
| Fax |
|
| Email |
preeti.620@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anjali Vaishnav |
| Designation |
MD SCHOLAR |
| Affiliation |
National Institute of Ayurveda Jaipur (Raj.) |
| Address |
DEPARTMENT OF ROGA NIDANA EVAM VIKRITI VIGYANA
National Institute of Ayurveda Deemed To Be University (De-novo) Jorawar Singh
Gate Amer Road Jaipur (Raj.)
Jaipur
RAJASTHAN
302002
India |
| Phone |
8696798497 |
| Fax |
|
| Email |
anjalivaishnav632@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Jaipur |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Jaipur |
| Address |
National Institute of Ayurveda Deemed To Be University (De-novo) Jorawar Singh
Gate Amer Road Jaipur (Raj.) - 302002 |
| 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 Anjali Vaishnav |
National Institute of Ayurveda (NIA) Hospital |
OPD-17, Department of roga nidana evam vikriti vigyan Jorawar Singh Gate, Amer Road, Jaipur, Rajathan 302002
Jaipur
RAJASTHAN |
8696798497
anjalivaishnav632@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K638||Other specified diseases of intestine. Ayurveda Condition: GRAHANIDOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals aged between 18–60 years of either sex.
Patients with symptoms of Muhurbaddham-Muhurdrava, Mala Pravritti, Muhur
Muhurmala- pravritti, Ama-Malapravritti,lakshanas of Grahani .
Participants who can understand the study protocol and provide informed consent. |
|
| ExclusionCriteria |
| Details |
Pregnant or lactating women.
Patients with severe comorbidities such as cardiovascular disease, diabete
mellitus, chronic kidney disease, or other chronic illnesses that might interfere
study. Individuals on long-term medication that may affect gut health
(e.g.antibiotics,steroids).
Patients with history of major gastrointestinal surgeries.
Patients with severe psychiatric disorders that may affect symptom reporting.
Individual with severe mental health disorders (e.g.depression,anxiety disorders,
psychosis) that might affect their ability to understand and follow the study
protocols. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Prevalence of predominant causative factors (Hetu), Purvarupa (prodromal symptoms)
and Rupa (clinical manifestations) in patients of Grahani.
Assessment of Relieving Factors (Upashaya) in current perspective
Samprapti pattern of Grahani in present time. |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Analysis of symptom patterns across age, gender, & occupation.
Identification of high-risk groups based on survey findings.
Development of an evidence-based framework for diagnosing & managing Grahani
dosha. |
18 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
20/01/2026 |
| 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="7"
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
|
This dissertation proposes a cross-sectional observational study to evaluate the application and clinical relevance of Nidana Panchaka (etiology, prodromal symptoms, clinical features, relieving factors, and pathogenesis) in patients suffering from Grahani, an Ayurvedic gastrointestinal disorder associated with impaired digestion. Conducted at the National Institute of Ayurveda, Jaipur, the study will assess 50 patients using structured questionnaires, clinical evaluation, and basic laboratory investigations. The research aims to identify the prevalence and patterns of Nidana Panchaka components in the present-day population, analyze their association with modern lifestyle and dietary factors, and bridge classical Ayurvedic concepts with contemporary clinical presentations. The findings are expected to support evidence-based diagnostic and management strategies for Grahani in current clinical practice |