| CTRI Number |
CTRI/2019/01/016894 [Registered on: 03/01/2019] Trial Registered Prospectively |
| Last Modified On: |
03/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To assess the role of wholesome diet in digestive disorders |
|
Scientific Title of Study
|
A Randomized Controlled Trial to Assess the Effect of Pathya Ahara in Grahani |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mamta Saini |
| Designation |
M.D. scholar , Department of Swasthavritta and Yoga |
| Affiliation |
|
| Address |
Dept. Of Swathavritta and Yoga ,National Institute Of Ayurveda, near
Jorawar Singh Gate Amer road
Jaipur
RAJASTHAN
302002
India |
| Phone |
8824999191 |
| Fax |
|
| Email |
drmamtasaini90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VAIDYA KAMALESH KUMAR SHARMA |
| Designation |
Professor & H.O.D. Department of Swasthavritta and Yoga |
| Affiliation |
|
| Address |
Dept.Of Swathavritta and Yoga National Institute Of Ayurveda near
Jorawar Singh Gate Amer Road
Jaipur
RAJASTHAN
302002
India |
| Phone |
9413345633 |
| Fax |
|
| Email |
kksayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vaidya Kashinath Samagandi |
| Designation |
Assitant proffesor , Department of Swasthavritta and Yoga |
| Affiliation |
|
| Address |
Dept. Of Swathavritta and Yoga,National Institute Of Ayurveda, near
Jorawar Singh Gate Amer Road
Jaipur
RAJASTHAN
302002
India |
| Phone |
7877444353 |
| Fax |
|
| Email |
kashisri@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda
Jaipur,dept. of swasthavritta and yoga OPD no- 21 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Near Jorawar Singh Gate Amer Road Jaipur
Rajasthan |
| 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 Mamta Saini MDscholar |
National institute of ayurveda |
Dept. of swasthavritta and yoga
OPD no. - 21
Jaipur
RAJASTHAN |
8824999191
-
drmamtasaini90@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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
5 grams of bilvachurna and 1 grams of panchkol churna |
Group A – 5 grams of Bilva churna and 1 grams of Panchkol churna mixed with each other will be given twice a day before major meals.
|
| Comparator Agent |
5 grams of bilva churna and 1 grams of panchkol churna with diet module |
Group B – A printed diet chart will be prepared and patients will be advised to follow that diet module along with Bilva & Panchkol Churna. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Classical sign and symptoms of Grahani.
2.Patients of either sex
3.Patients in the age group of 18 to 60 years.
4.Patients willing and able to carry out treatment for 6 weeks.
5.Patients will be registered with duly signed informed consent prior to the trial
|
|
| ExclusionCriteria |
| Details |
1.Known case of with sever I.B.S
2.Known case of peptic ulcer , ulcerative colitis , pancreatitis , coeliac disease
3.Patients taking any other treatment of Grahani, I.B.S. and chronic Amoebiasis
4.Known case of suffering from any systematic disorder.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvements in dependent variables |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in quilty of life of patients |
45 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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
05/01/2019 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Grahani
has been
widely described in the various Ayurvediya
literatures. Grahani is a syndrome in
which Agni, the digestive power, is
supposed to be at fault. When Agni
becomes depressed ama dosha (undigested
waste material) accumulates and passed in the stool.Grahani
has been
widely described in the various Ayurvediya
literatures. Grahani is a syndrome in
which Agni, the digestive power, is
supposed to be at fault. When Agni
becomes depressed ama dosha (undigested
waste material) accumulates and passed in the stool. The role of diet is very important,
while treating the patient of the Grahani.
Till now no work has been found on Ahara
for Grahani. Therefore, this gap of
knowledge is being tried to fulfill in this study.
|