| CTRI Number |
CTRI/2014/09/005066 [Registered on: 25/09/2014] Trial Registered Prospectively |
| Last Modified On: |
09/09/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
CLINICAL EVALUATION OF KUTAJARISHTA IN THE MANAGEMENT OF IRRITABLE BOWEL SYNDROME (IBS) |
|
Scientific Title of Study
|
CLINICAL EVALUATION OF KUTAJARISHTA IN THE MANAGEMENT OF IRRITABLE BOWEL SYNDROME (IBS) |
| Trial Acronym |
KIMIBS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harbans Singh |
| Designation |
Research Officer (Ayurveda) |
| Affiliation |
National Institute of Ayurvedic Pharmaceutical Research |
| Address |
National Institute of Ayurvedic Pharmaceutical Research Moti Bagh Road Patiala
National Institute of Ayurvedic Pharmaceutical Research Moti Bagh Road Patiala
Patiala
PUNJAB
147001
India |
| Phone |
09501248820 |
| Fax |
01752223663 |
| Email |
dr.harbans@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Sannd |
| Designation |
Institute Incharge & RO (Scientist 3) |
| Affiliation |
National Institute of Ayurvedic Pharmaceutical Research |
| Address |
National Institute of Ayurvedic Pharmaceutical Research
Moti Bagh Road Patiala
Patiala
PUNJAB
147001
India |
| Phone |
09316223524 |
| Fax |
01752223663 |
| Email |
sanndrajesh@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Sannd |
| Designation |
Institute Incharge & RO (Scientist 3) |
| Affiliation |
National Institute of Ayurvedic Pharmaceutical Research |
| Address |
National Institute of Ayurvedic Pharmaceutical Research
Moti Bagh Road Patiala
Patiala
PUNJAB
147001
India |
| Phone |
09316223524 |
| Fax |
01752223663 |
| Email |
sanndrajesh@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences,
Department of AYUSH,
Min. of Health and Family Welfare,
New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences |
| Address |
JLNBCEHAB 61 to 65 Institutional area Opp D Block Janakpuri New Delhi 110058 |
| 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 |
| Dr Krishna Kumari |
Ayurvedic Regional Research Institute, |
Rajinder Nagar
Bantalab
Jammu
JAMMU & KASHMIR |
09419183684
drkrishnakumari02@gmail.com |
| Dr S K Sharma |
Ayurvedic Regional Research Institute, |
Gandhi Bhawan
Tehsil Sadar
Mandi
HIMACHAL PRADESH |
09418062731
01905222852
dr.sk.sharma.ad@gmail.com |
| Dr Harbans Singh |
National Institute of Ayurvedic Pharmaceutical Research (NIAPR), |
Moti Bagh Road
Patiala
PUNJAB |
09501248820
01752223663
dr.harbans@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| IEC NIAPR Patiala |
Approved |
| IEC, ARRI, Jammu |
Approved |
| IEC, ARRI, Mandi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
CLINICAL EVALUATION OF KUTAJARISHTA IN THE MANAGEMENT OF IRRITABLE BOWEL SYNDROME (IBS), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kutjarishta
API-2 Vol-2 pp39 |
Kutjarishta is an Ayurvedic classical preparation advocated for the cure of Sangrahini (IBS). It consists of ingredients like
Kutaja (Stem Bark of Holarrhena antidysentrica)
Draksha (dried fruid of Vitis vinifera)
Madhuka Pushpa (Flowers of Madhuka indica)
Gambhari (Stem Bark of Gmelina arborea)
Water for decoction
Jaggery and flowers of Woodfordia fruticosa for fermentation.
Dose: 25 ml twice daily with equal quantity of water
Route of Administration: Oral
Time of administration:Twice a day after food |
| Comparator Agent |
Nil |
No agent is required for the comparison |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Known case of IBS of subtype mixed( IBS-M) as per Rome III criteria :
Recurrent abdominal pain or discomfort for at least 3 months, and symptoms at least 3 days/month associated with two or more of the following:
• Relief of pain or discomfort with defecation.
• Onset of pain or discomfort associated with a change in form (appearance) of stool (loose or hard stools): Bristol stool form scale of type 1-2 for constipation and type 6-7 for diarrhoea.
• Onset of pain or discomfort associated with a change in bowel frequency: ≤ 3 bowel movements per week for constipation and > 3 bowels movements per day for diarrhoea.
2. Willing to give written informed consent for the participation.
|
|
| ExclusionCriteria |
| Details |
1. Known cases of Gastroesophageal Reflux Disease(GERD)/hyperacidity
2. Patients with bleeding per rectum.
3. Mixed infection with parasites like round worms, hook worms etc.
4. Patients with evidence of malignancy
5. Patients with Diabetes Mellitus {B.S. (F) > 126 mg/dl and / or B.S. (2 hr. PP) >200 mg/dl
6. Patients on prolonged (> 6 weeks) medication with corticosteroids, 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 P.I.
8. Patient having history of unstable cardiovascular disease
9. Symptomatic patients with clinical evidence of heart failure.
10. Patients with concurrent 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),
Pulmonary Dysfunction (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 inflammatory bowel disease and coeliac disease.
13. Family history of gastrointestinal malignancy.
14. H/o hypersensitivity to the trial drug or any of its ingredients.
15. Pregnant / lactating woman.
16. Patients who have completed participation in any other clinical trial during the past six (06) months.
Any intestinal pathology which the 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 |
| Assessment of the effect of Kutajarishta on IBS Severity score |
Time frame:from baseline to on 14th day,28th day,42th day,56th day,and 70th day, end of 12th week and 14th week) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of the effect of Kutajarishta on WHO-QOL BREF score |
[Time frame: at base line, at end of 12th week and 14th week] |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
01/10/2014 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Irritable Bowel Syndrome (IBS) is a highly prevalent condition, affecting 15% of the population. Irritable Bowel Syndrome is a clinical entity recently identified with a set of symptoms related to gastrointestinal tract. These symptoms essentially pertain to the diathesis of gut motility disorder. This characteristic clinical features are abdominal pain, altered bowel habit, psychiatric symptoms such as anxiety or depression in the absence any detectable organic pathology. It is a persistent syndrome intractable to all kinds of treatment and presentation often appears intermingled with a range of personality factors. IBS seems to be apparently comparable to two classical Ayurvedic syndromes described in Samhitas of Ayurveda viz. (1) Vataja Grahani Roga (2) Pakvasayagata Vata. On further, conceptual and clinical studies on IBS and its probable correlates in Ayurveda suggest that the description of Pakvasayagata Vata is very close to IBS, not only symptoms but the site Pakvasaya (Colon) is also common in both the conditions. The current management of IBS is not satisfactory. Ayurveda in its herbarium has lots of antidiarrhoeal and antibacterial compounds which can fill up this gap. On the textual and on the basis of clinical experience drug Kutajarishta (API- Part II Vol –II: Pg No.39) is selected as antidiarrhoeal and antibacterial agent for the clinical trial in patients of Irritable Bowel Syndrome (IBS). After examining the pharmacological properties and pharmacological actions of constituents of selected Kutajarishta, The present clinical trial is planned to validate the clinical efficacy and safety of Kutjarishta in the subjects suffering from Irritable Bowel Syndrome (IBS) Various ingradients of Kutjarishta are: 1. Kutaja (Stem bark of Holarrhena antidysenterica) 2. Draksha (Dried fruit of Vitis vinifera) 3. Madhuka pushpa (Flowers of Madhuka indica) 4. Gambhari (Stem Bark of Gmelina arborea) 5. water for decoction 6. Guda (Jaggery) 7. Dahtki pushpa (flowers of Woodfordia fruticosa |