| CTRI Number |
CTRI/2021/03/031799 [Registered on: 08/03/2021] Trial Registered Prospectively |
| Last Modified On: |
08/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Clinical Study Of Medicated Enema With Shatpala Ghrita And Kshara Ghrita In The Management Of Grahani Roga |
|
Scientific Title of Study
|
A Comparative Clinical Study Of Matrabasti With Shatpala Ghrita And Kshara Ghrita In The Management Of Grahani Roga |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rakesh Kumar Mishra |
| Designation |
PG Scholar |
| Affiliation |
Rajiv Gandhi Education Societys Ayurvedic Medical College And Hospital Ron Dist Gadag Karnataka |
| Address |
Department of Panchakarma
Rajiv Gandhi Education Societys Ayurvedic Medical College And Hospital Ron Dist-Gadag Karnataka
Rajiv Gandhi Education Societys Ayurvedic Medical College And Hospital Ron Dist-Gadag Karnataka
Gadag
KARNATAKA
582209
India |
| Phone |
9993907898 |
| Fax |
|
| Email |
dr.rakeshmishra02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr I B Kotturshetti |
| Designation |
Guide and HOD |
| Affiliation |
Rajiv Gandhi University of Health Sciences,Bangalore Karnataka |
| Address |
Rajiv Gandhi Education Societys Ayurvedic Medical College And Hospital Ron Dist Gadag Karnataka
Rajiv Gandhi Education Societys Ayurvedic Medical College And Hospital Ron Dist Gadag Karnataka
Gadag
KARNATAKA
582209
India |
| Phone |
09448236038 |
| Fax |
|
| Email |
dribkotturshetty@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakesh Mishra |
| Designation |
PG Scholar |
| Affiliation |
Rajiv Gandhi University of Health Sciences,Bangalore Karnataka |
| Address |
Department of Panchakarma Rajiv Gandhi Education Societys Ayurvedic Medical College Ron District Gadag Karnataka
Rajiv Gandhi Education Societys Ayurvedic Medical College, Ron District Gadag Karnataka
Gadag
KARNATAKA
582209
India |
| Phone |
9993907898 |
| Fax |
|
| Email |
dr.rakeshmishra02@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD of RGES Ayurvedic Medical College and Hospital Ron Dist Gadag Karnataka |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Department of Panchakarma Rajiv Gandhi Education Societys Ayurvedic Medical College And Hospital Ron Dist Gadag Karnataka |
| Type of Sponsor |
Other [Other (self)] |
|
|
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 Rakesh Kumar Mishra |
RGES Ayurvedic Medical College and Hospital Ron Dist Gadag Karnataka |
Department of Panchakarma Basti Room Ground Floor
Gadag
KARNATAKA |
9993907898
dr.rakeshmishra02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Research on Human Subjects Rajiv Gandhi Education Societys Ayurvedic Medical College And Hospital Ron Dist Gadag Karnataka |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K582||Mixed irritable bowel syndrome, (2) ICD-10 Condition:K582||Mixed irritable bowel syndrome. Ayurveda Condition: GRAHANIDOSHAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Kshara Ghrita Matrabasti |
Aama-pachana with Ajamodadi Churna 3 gms Three times in a Day with Luke warm water before meal up to first 3 days to Both Group A and B. 1½ Pal( 72 ml)31 Matrabasti with Shatpala Ghrita will be administrated to Group A and 1½ Pal( 72 ml) Matrabasti with Kshara Ghrita will also be administrated to Group B for the planned study design |
| Intervention |
Shatapal Ghrita Matrabasti |
Aama-pachana with Ajamodadi Churna 3 gms Three times in a Day with Luke warm water before meal up to first 3 days to Both Group A and B.
1½ Pal( 72 ml)31 Matrabasti with Shatpala Ghrita will be administrated to Group A and 1½ Pal( 72 ml) Matrabasti with Kshara Ghrita will also be administrated to Group B for the planned study design. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with clinical sign and symptoms of Grahani roga like Muhur badda muhur drava mala pravritti, Udara Shoolaa, Amayuktha mala pravritti, Muhur muhur mala pravritti,Udara Gaurava, Arochaka, Avipaka.
2. Patients between age group of 16 to 50 years.
3. Patients who is suffering from chronic Grahani roga up to 2 years.
4. Patients irrespective of sex, religion, occupation.
5. Patients who is fit for Matrabasti.
|
|
| ExclusionCriteria |
| Details |
1. Patients suffering from Amoebiasis, Tropical sprue, Malabsorption syndrome, Ulcerative colitis, Crohn‟s disease, coeliac disease.
2. Patients suffering from Carcinoma of stomach and intestine,
Tuberculosis.
3. Patients suffering from Pregnancy.
4. Patients suffering from any serious life threatening disease like HIV,IHD
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Use of Shatpala Ghrita and Kshara Ghrit is effective in the management of Grahani Roga |
4 weeks to 7 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Along with target disease treatment we also find some guideline to treat similar type of intestinal disease/disorder |
4 weeks to 7 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
10/03/2021 |
| 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="1"
Days="18" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The cardinal features of Grahaniroga explained
in the clinical text books of Ayurveda, have at most similarities with the
clinical features of Irritable Bowel
Syndrome (IBS) explained in western medicine.
The symptoms of Irritable Bowel Syndrome (IBS) are abdominal pain, cramping, diarrhea, constipation, gas,
bloating, food intolerance with fatigue and difficulty in sleeping.
At
present the number of people suffering from the gastro-intestinal diseases.
Among these Grahaniroga in the society is constantly increasing. According
to a survey which are based on modern medicine parameter i.e. IBS approximately10-20
% (in Western Country) and 4.2 -7.9 % (In India) are becoming affected from Grahani
roga. In the Grahnirogathere is group of symptoms
are found. It is not possible to diagnose it with any single symptom. There are several
Ayurvedic drug mentioned in Ayurvedic classics for the treatment of Grahaniroga.
Among these Ayurvedic drugs I have chosen Shatpala Ghrita and Kshara
Ghrita. In this
context ShatpalaGhrita is one of the Ayurvedic drug which is very
effective in the treatment of Grahaniroga which is mentioned in
the AstangaHrudaya. In the same way KsharaGhrita
is another Ayurvedic drug which is very effective in the treatment of Grahaniroga
which is mentioned in the CharakChikitsa.
|