| CTRI Number |
CTRI/2024/12/077946 [Registered on: 11/12/2024] Trial Registered Prospectively |
| Last Modified On: |
03/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management oF Grahani Roga Through Ayurveda |
|
Scientific Title of Study
|
An Exploratory Study of Vishwadhya Churna in the Management of Grahani Roga |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nisha Kumari Meena |
| Designation |
Pg Scholar |
| Affiliation |
post graduate institute of ayurved, jodhpur |
| Address |
P.G. Department of Kayachikitsa Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved
University Jodhpur
Rajasthan
342037
India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9352714138 |
| Fax |
|
| Email |
nityasingh354@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pramod Kumar Mishra |
| Designation |
professor and hod |
| Affiliation |
post graduate institute of ayurved, jodhpur |
| Address |
P.G. Department of Kayachikitsa Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved
University Jodhpur
RAJASTHAN
342037
India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9001009793 |
| Fax |
|
| Email |
drpramodmishra4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nisha Kumari Meena |
| Designation |
Pg Scholar |
| Affiliation |
Post graduate institute of ayurved, jodhpur |
| Address |
P.G. Department of Kayachikitsa Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved
University Jodhpur
Rajasthan
342037
India
Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved
University Jodhpur
Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9352714138 |
| Fax |
|
| Email |
nityasingh354@gmail.com |
|
|
Source of Monetary or Material Support
|
| post graduate institute of ayurved jodhpur 342037 Rajasthan India |
|
|
Primary Sponsor
|
| Name |
post graduate institute of ayurved jodhpur |
| Address |
P.G. Department of Kayachikitsa Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved
University Jodhpur
RAJASTHAN
342037
India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR NISHA KUMARI MEENA |
P.G. Department of Kayachikitsa Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved
University Jodhpur
RAJASTHAN
342037
India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nisha Kumari Meena |
post graduate institute of ayurved jodhpur |
P.G. Department of Kayachikitsa Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved
University Jodhpur
Rajasthan
342037
India
Jodhpur
RAJASTHAN |
9352714138
nityasingh354@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Post Graduate Institute of Ayurved Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: GRAHANIDOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: VISHWADHYA CHURNA, Reference: ग.नि. गà¥à¤°à¤¹à¤£à¥€ 3, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: LUKEWARM WATER), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having age between 18-70 years of either sex presenting with clinical features of Grahani Roga
Patient willing to sign the consent form
Patients having symptoms of Grahani Roga |
|
| ExclusionCriteria |
| Details |
Pregnant women and lactating mothers. Mixed infections with parasites such as round worms, hook worms etc. Infectious disorders like intestinal tuberculosis. Patients with bleeding per rectum. Patients with evidence of malignancy. Abuse of drug or alcohol.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Assessment of Subjective and Objective Parameters Before and After Treatment |
60 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe any side effects if occur during clinical trial |
60 Days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
14/12/2024 |
| 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="0"
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
|
INTRODUCTION Grahani is shashthi pittadharakala situated in between the stomach and the large intestine.
[su.utr.40/169] Acharaya Charka says that Grahani is the seat of Agni and called so because of
holding up the food. Normally, it holds up the food (until it is digested) and releases it from the
side after it has been digested, but when disrupted by a sluggish digestive fire (Mandagni), the
digested substance is released even in unripe conditions. This state of the working of Grahani is
called Grahani Roga. [ch.chi.15/56-57]
Samana Vayu, pachaka pitta and kledaka kapha are the main doshas confined to the organ
Grahani. Grahani Roga is a disease of Annavaha srotas caused due to the production of Ama and
Mandagni. Functionally weak agni i.e., Mandagni causes improper digestion of ingested food
which leads to Grahani Roga. Due to improper digestion of food, there is vitiation of the Dosha
and Agni and symptoms like alternate Constipation and Diarrhoea, with associated symptoms are
seen, which can be collectively called as Grahani Roga. if left untreated Grahani Roga ensues
with symptomatology like udarashoola, adhmana, arochaka, avipaka, muhurbadha muhurdrava
mala pravatti, durgandhita mala pravatti, klama etc. In the present era, GrahaniRoga is a common
GI tract disorder affecting daily life because of its direct link with improper food habits and stressful
lifestyle. Globally prevalence of Grahani about (11.2%) and Indian prevalence is (4.2- 7.7%).
METHOD OF PREPARATION OF TRIAL DRUG All the herbal drugs will be collected in their proper collecting time and in dry forms. All
these dried herbal ingredients will be taken in equal quantity. Then all the dried herbs will be
grinded very finely, filtered with a cotton cloth and mixed with each other thoroughly. Drugs will
be prepared in pharmacy of University College of Ayurveda Jodhpur. |