| CTRI Number |
CTRI/2012/01/002348 [Registered on: 18/01/2012] Trial Registered Retrospectively |
| Last Modified On: |
06/01/2012 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to see the effect of an Ayurvedic formulation in the patients of Irritable Bowel Syndrome |
|
Scientific Title of Study
|
Clinical Evaluation of Bilvadi Leha in the Management of Irritable Bowel Syndrome (IBS) |
| Trial Acronym |
ACT- IBS-2010 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pradeep Dua |
| Designation |
Research Officer (co-ordinator ACT project) |
| 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, Janakpuri, New Delhi
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri, New Delhi
West
DELHI
110058
India |
| Phone |
011-28525831 |
| Fax |
011-28520748 |
| Email |
duadrpradeep@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep Dua |
| Designation |
Research Officer (co-ordinator ACT project) |
| 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, Janakpuri, New Delhi
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri, New Delhi
West
DELHI
110058
India |
| Phone |
011-28525831 |
| Fax |
011-28520748 |
| Email |
duadrpradeep@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Dua |
| Designation |
Research Officer (co-ordinator ACT project) |
| 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, Janakpuri, New Delhi
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri, New Delhi
West
DELHI
110058
India |
| Phone |
011-28525831 |
| Fax |
011-28520748 |
| Email |
duadrpradeep@gmail.com |
|
|
Source of Monetary or Material Support
|
| Support in terms of infrastructural facilities:
1. National Institute of Ayurveda (NIA), Jaipur
2. Rajiv Gandhi Government Post-Graduate Ayurvedic College, Paprola
3. Institute of Post-Graduate Training & Research in Ayurveda (IPGT&RA), Jamnagar |
|
|
Primary Sponsor
|
| Name |
Department of AYUSH Ministry of Health Family Welfare Government of India |
| Address |
Department of AYUSH, Ministry of Health & Family Welfare,
Government of India, IRCS Building, Red Cross Road, New
Delhi-110001. |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof M S Baghel Ramanand Tiwari |
Institute of Post-Graduate Training & Research in Ayurveda (IPGT&RA) |
Office of the Director and the Department of Kayachikitsa, Gujarat Ayurved University, Jamnagar-361001
Jamnagar
GUJARAT |
9427207964
91-288-2676856
baghelayu@rediffmail.com |
| Dr Daya Shankar Mishra Dr Gurpreet Kaur |
National Institute of Ayurveda (NIA) |
Department of Kayachikitsa, Amer Road, Madhav Vilas Palace, Jaipur-302002
Jaipur
RAJASTHAN |
9414240060
0141-2635709
nagarmishra@yahoo.com |
| Prof YK Sharma Dr Uzma Siddiqui |
Rajiv Gandhi Government Post-Graduate Ayurvedic College |
Department of Kayachikitsa, Paprola, District Kangra-176115
Kangra
HIMACHAL PRADESH |
9418007291
01894242064
dryks2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, National Institute of Ayurveda (NIA), Jaipur |
Approved |
| Institutional Ethics Committee, IPGT&RA, Jamnagar, Gujarat, India |
Approved |
| Institutional Ethics Committee, Rajiv Gandhi Government Post-Graduate Ayurvedic College, Paprola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Irritable Bowel Syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bilvadi Leha |
Dose – 10 gm twice daily
Dosage form - Avleha-
Route of Administration – Oral
Time of Administration-Twice a day after food
Anupana-Lukewarm
Water
Packing form- 300 gm pet jar
Duration of therapy-12 weeks
|
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex with age between 18 and 65 years
2. Known case of IBS as per Rome III criteria :
(Symptoms of recurrent abdominal pain or discomfort and a marked change in
bowel habit for atleast six months, with symptoms experienced on atleast 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 frequencey of stools
· Onset assoicated with a change in form (appearance) of stools.
(Diagnosis to be confirmed by using the IBS module questionnaire)
3. Willing and able to participate in the study |
|
| 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% OR HbA1c> 6.5%}.
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 major systemic illness necessitating long term drug
treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal
disorders, etc.)
8. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome,
Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
9. Symptomatic patient with clinical evidence of Heart failure.
10. 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 >1.2mg/dL), Severe 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
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Global Improvement in signs and symptoms of IBS (IBS severity score)
|
At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 16th 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 16th week. |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
20/01/2011 |
| 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="1"
Months="6"
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 all the three centers. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aimed at scientific validation of the clinical efficacy and safety of twenty nine (29) classical Ayurvedic pharmacopoeial formulations, multicentre clinical trials have been initiated as an activity under the Ayurveda Clinical Trials (ACT) project of the Ayurvedic Pharmacopoeia committee (APC) during July-August 2010 in eighteen (18) disease conditions involving fifty four (54) M.D/PhD (Ay.) research scholars in eight (08) postgraduate Ayurveda colleges across the country. Bilvadi Leha is a poly herbal preparation containing Bilva (Aegle marmelos), Musta (Cyperus rotundus), Dhanyaka (Coriandrum sativum), Jiraka (Cuminum cyminum), Sukshma ela (Elettaria cardamomum), Tvak (Cinnamomum zeylanicum), Nagkesara (Mesua ferrea), Sunthi (Zingiber officinale), Marica (Piper nigrum), Pippali (Piper longum) and Jirna Guda (Old Jaggery).
Bilvadi leha has been in use since ages, and has been found to be useful in treating Irritable Bowel Syndrome and promoting the health. The present study is being undertaken in three post graduate Ayurveda colleges involving the post graduate scholars who are doing the clinical trials to scientifically study and validate the clinical efficacy and safety of this Ayurvedic formulation as a part of their Post Graduate (PG) Thesis.
The Central Council for Research in Ayurvedic Sciences (CCRAS) is the nodal organization to co-ordinate and monitor these trials. CCRAS has provided the necessary infrastructure to the participating colleges, technical inputs (including the clinical trial protocols), trial drugs and training to the researchers involved in the project. |