| CTRI Number |
CTRI/2024/09/073874 [Registered on: 13/09/2024] Trial Registered Prospectively |
| Last Modified On: |
12/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Investigating the Association between Emaciation(Karshya) and Grahani roga: An observational Cross-Sectional Study |
|
Scientific Title of Study
|
To generate the empirical evidence for association of Karshya (emaciated)
individuals and Grahani roga– An observational cross-sectional study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MAHIMA SAHU |
| Designation |
P.G SCHOLAR |
| Affiliation |
Mahatma Gandhi Ayurved College, Hospital And Research Centre |
| Address |
Department of Samhita and Siddhant Division- 2 Room no- 22,
MAHATMA GANDHI AYURVED COLLEGE HOSPITAL AND
RESEARCH CENTRE SALOD (H) WARDHA MAHARASHTRA
Wardha
MAHARASHTRA
Wardha
MAHARASHTRA
442001
India |
| Phone |
7898643063 |
| Fax |
|
| Email |
mahimasahu111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mahima Sahu |
| Designation |
PG Scholar |
| Affiliation |
MAHATMA GANDHI AYURVED COLLEGE HOSPITAL AND RESEARCH CENTRE SALOD (H) WARDHA MAHARASHTRA |
| Address |
Department of Samhita and Siddhant Division-2 Room no-22,
MAHATMA GANDHI AYURVED COLLEGE HOSPITAL AND RESEARCH CENTRE SALOD (H) WARDHA MAHARASHTRA
Wardha
MAHARASHTRA
442001
India |
| Phone |
7898643063 |
| Fax |
|
| Email |
mahimasahu111@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preeti Borkar |
| Designation |
Professor |
| Affiliation |
MAHATMA GANDHI AYURVED COLLEGE HOSPITAL AND RESEARCH CENTRE SALOD (H) WARDHA MAHARASHTRA |
| Address |
Department of Samhita and Siddhant Division-2 Room no-22, MAHATMA GANDHI AYURVED COLLEGE HOSPITAL AND RESEARCH CENTRE SALOD H WARDHA MAHARASHTRA
Wardha
MAHARASHTRA
442001
India |
| Phone |
8446127058 |
| Fax |
|
| Email |
preeti.borkar@dmiher.edu.in |
|
|
Source of Monetary or Material Support
|
| Acharya Vinoba Bhave Rural Hospital Sawangi (Meghe) Wardha Maharashtra 442004 Pin -
442001 INDIA
|
| Mahatma Gandhi Ayurved College Hospital and Research Centre Salod(H) Wardha Maharashtra
Pin - 442001 INDIA |
|
|
Primary Sponsor
|
| Name |
Dr Mahima Sahu |
| Address |
Mahatma Gandhi Ayurved College Hospital and Research Centre
Salod (H) Wardha Maharashtra Pin - 442001 INDIA |
| Type of Sponsor |
Private 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 Mahima sahu |
Mahatma Gandhi Ayurved College ,Hospital and Research Centre Wardha (Hirapur) 442001 |
OPD and IPD Dept of
Kayachikitsa
MGACH&RC Salod (H)
Wardha 442001
Wardha
MAHARASHTRA
Wardha
MAHARASHTRA |
7898643063
mahimasahu111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee Salod (H) ,Wardha-442004, Maharashtra, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K318||Other specified diseases of stomach and duodenum. Ayurveda Condition: GRAHANIDOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing for written informed consent to participate in the study.
Patient between the age group of 18 to 60 years of either gender.
Patient fulfilling the both subjective and objective criteria of Karshyata (emaciation).[15] Patients with clinical sign and symptoms of Grahani roga in classical ayurvedic texts and modern
literature.
Abdominal pain, flatulence and bloating that have been present for at least 3 Months. |
|
| ExclusionCriteria |
| Details |
Subjects who are having infectious diseases like tuberculosis, congenital and hereditary problems,
malignancies, mal absorption syndromes and metabolic disorders repeated worm manifestation.
• Individual with anaemic condition
• Known case of HIV infection
• Known case of abnormal / dysfunctional uterine bleeding.
• Known case of CKD, CLD, CAD, Cancer. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Prevalence of Grahani Roga in Karshya(Emaciated) Individuals:
The primary outcome will measure the percentage of individuals diagnosed with Grahani Roga among the emaciated population (Karshya). |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nutritional status and dietary patterns: Evaluating the nutritional status and dietary habits of individuals with Grahani roga compared to those without , within the emaciated population. |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="382"
Sample Size from India="382"
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)
|
25/09/2024 |
| 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="2"
Months="0"
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
|
The volunteers will be informed about the study protocol .Willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and Validated prior to the study approval will be taken from IEC, MGACHRC, SALOD (H) Wardha and CTRI RAGISTRATION will be done . after selection each participant will be tested individually and selected according to selection criteria . there will be only single group which include 382 individuals. |