| CTRI Number |
CTRI/2016/01/006550 [Registered on: 21/01/2016] Trial Registered Retrospectively |
| Last Modified On: |
21/01/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to investigate the effect of Brihat Gangadhar Churna in the treatment of Irritable bowel syndrome |
|
Scientific Title of Study
|
Clinical Efficacy and Safety of Brihat Gangadhara Churna in the Management of Irritable Bowel Syndrome (IBS) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Debajyoti Das |
| Designation |
Research Officer(Ayu.) Principal Investigator |
| Affiliation |
National Research Institute of Ayurvedic Drug Development |
| Address |
National Research Institute of Ayurvedic Drug Development
4 CN Block, Sector-V, Bidhannagar, Kolkata-700 091,
West Bengal
India
National Research Institute of Ayurvedic Drug Development
4 CN Block, Sector-V, Bidhannagar, Kolkata-700 091,
West Bengal
India
Kolkata
WEST BENGAL
700 091
India |
| Phone |
08648830799 |
| Fax |
03323671001 |
| Email |
debajyoti.das02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B S Sharma |
| Designation |
Research Officer (Nodal Officer) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences (CCRAS) |
| Address |
Central Council for Research in Ayurvedic Sciences (CCRAS, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan,
61-65,Institutional Area, Opposite D Block,Janakpur.
Central Council for Research in Ayurvedic Sciences (CCRAS, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan,
61-65,Institutional Area, Opposite D Block,Janakpuri.
New Delhi
DELHI
110058
India |
| Phone |
09968485854 |
| Fax |
01128520748 |
| Email |
bss_ro@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr B S Sharma |
| Designation |
Research Officer (Nodal Officer) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences (CCRAS) |
| Address |
Central Council for Research in Ayurvedic Sciences (CCRAS, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan,
61-65,Institutional Area, Opposite D Block,Janakpur.
Central Council for Research in Ayurvedic Sciences (CCRAS, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan,
61-65,Institutional Area, Opposite D Block,Janakpuri.
New Delhi
DELHI
110058
India |
| Phone |
09968485854 |
| Fax |
01128520748 |
| Email |
bss_ro@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Support in terms of infrastructural facilities: National Research Institute of Ayurvedic Drug Development , Kolkata-700 091, West Bengal |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences CCRAS |
| Address |
Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri, New Delhi-110058, INDIA |
| Type of Sponsor |
Research institution |
|
|
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 Debajyoti Das |
National Research Institute of Ayurvedic Drug Development (NRIADD) , Kolkata, West Bengal |
National Research Institute of Ayurvedic Drug Development.4 CN Block, Sector-V, Bidhannagar, Kolkata-700 091,
West Bengal
India
Kolkata
WEST BENGAL |
033-23673808
033-23671001
debajyoti.das02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, NRIADD, Kolkata |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Irritable Bowel Syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brihat Gangadhara Churna |
Dose-3 gm twice daily
Dosage form - Churna
Route of Administration-Oral
Time of Administration-Twice a day after food
Anupana -Honey
Duration of therapy-12 weeks
Sample Size-90 Level of study-OPD level Type of study-Interventional Purpose-Treatment Masking-Open lavel Control-Not controlled Group-Single Follow up Period-14 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Known case of IBS as per Rome III criteria :
(Symptoms of recurrent abdominal pain or discomfort and a marked change in bowel habit for at least six months, with symptoms experienced on at least 3 days/month in the last 3 months associated with two or more of the following:
Pain is relieved by defecation
Onset associated with change of frequency of stools (Constipation: < 3 - week, diarrhoea > 3/days
Onset associated with a change in form (Bristol Stool chart
Type 1-2 constipation, Type 6-7 diarrhea.
2. Willing and able to participate in the study for 14 weeks.
|
|
| ExclusionCriteria |
| Details |
1. Patients with bleeding per rectum.
2. Mixed infection with parasites like round worms, hook worms etc.
3. Patients with evidence of malignancy
4. Patients with Diabetes Mellitus {B.S. (F) > 126 mg% and / or B.S. (2 hr. PP)>200 mg%
5. Patient with poorly controlled Hypertension (> 160 / 100 mm Hg)
6. Patients on prolonged (> 6 weeks) medication with corticosteoids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study.
7. Patients suffering from any systemic illness affecting the bowel habits as assessed by PI.
8. Patients having history of unstable cardiovascular disease.
9. Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine >1.4mg/dL), Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), or any other condition that may jeopardize the study.
11. Alcoholics and/or drug abusers.
12. H/o hypersensitivity to the trial drug or any of its ingredients.
13. Pregnant / lactating woman.
14. Patients who have completed participation in any other clinical trial during the past six (06) months.
15. Any other condition which the Principal Investigator thinks may jeopardize the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Global Improvement in signs and symptoms of IBS |
At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 14th week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients who achieve improvement in Diarrhoea /Constipation. |
At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 14th week. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
08/05/2015 |
| 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) |
Open to Recruitment |
|
Publication Details
|
To be published after the completion of the clinical trials in center. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The Central Council for Research in Ayurvedic Sciences (CCRAS) is an autonomous body under the Department of AYUSH (Ayurveda, Yoga &Naturopathy, Unani, Siddha and Homeopathy), Ministry of Health & Family Welfare, Government of India. CCRAS is an apex body in India for the formulation, co-ordination, development and promotion of research on scientific lines in the Ayurveda system of medicine. Aimed at generating evidence for the scientific validation of the clinical efficacy and safety of classical Ayurvedic formulations, multicentre clinical trials have been initiated in peripheral institutes of the Council as an activity under the Intra Mural Clinical Research (IMR) program. Brihat Gangadhara Churna is a poly-herbal preparation containin: Bilva (Aegle marmelos), Musta (Cyperus rotundus), Shunthi (Zingiber officinale),Dhataki(woodfordia fruticosa),Araluka(Ailanthus excels),Lodhra(Symplocos racemosa), Balak(Pavonia odorata), Mocharasa(Salmalia malabarica),Patha(Cissampelos pareira),Indrayava (Holarrhena antidysentrica),Vatsaka(Holarrhena antidysentrica), Amrabeeja(Mangifera indica),Ativisa(Aconitum heterophyllum),Lajjalu(Mimosa pudica).The present study entitled “Clinical efficacy and safety of Brihat Gangadhara Churna in the management of Irritable Bowel Syndrome.†is being undertaken in one peripheral institute of the CCRAS.The cumulative evidence generated as an activity under the ACT project as well as IMR programme is expected to scientifically substantiate the claims regarding clinical efficacy and safety of this classical Ayurvedic formulation. |