CTRI Number |
CTRI/2019/09/021371 [Registered on: 23/09/2019] Trial Registered Prospectively |
Last Modified On: |
20/09/2019 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Single Arm Study |
Public Title of Study
|
Mustakarishta in the management of Irritable Bowel Syndrome |
Scientific Title of Study
|
Clinical evaluation of Mustakarishta in the management of Grahani |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
Not applicable |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Gurucharan Bhuyan MD Ay PhD R O Ay |
Designation |
Research Officer(Ay) |
Affiliation |
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES |
Address |
Central Ayurveda Research Institute for Hepatobiliary
Disorders,Bhubaneswar
Regional Ayurveda Research Institute for Gastro-Intestinal Disorders,Guwahati Khordha ORISSA 751029 India |
Phone |
06742387702 |
Fax |
06742387702 |
Email |
drbhuyangc@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Gurucharan Bhuyan |
Designation |
Research Officer(Ay) |
Affiliation |
Ayurveda Hospital CARIHD, BHUBANESWAR |
Address |
Central Ayurveda Research Institute for Hepatobiliary
Disorders,Bhubaneswar
Bharatpur
Bhubaneswar
Odisha
751029 Khordha ORISSA 751029 India |
Phone |
06742387702 |
Fax |
06742387702 |
Email |
drbhuyangc@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Gurucharan Bhuyan |
Designation |
Research Officer(Ay) |
Affiliation |
Ayurveda Hospital CARIHD, BHUBANESWAR |
Address |
Central Ayurveda Research Institute for Hepatobiliary Disorders,Bhubaneswar
Bharatpur
Bhubaneswar
Khurdha
751029 Khordha ORISSA 751029 India |
Phone |
06742387702 |
Fax |
06742387702 |
Email |
drbhuyangc@gmail.com |
|
Source of Monetary or Material Support
|
Ministry of AYUSH,Govt of India
INA; New Delhi; |
|
Primary Sponsor
|
Name |
CCRAS |
Address |
Institutional Area,Opposite D Block,
Janakpuri;New Delhi |
Type of Sponsor |
Other [Autonomous body under Ministry of AYUSH] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 2 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
DrGurucharan Bhuyan |
CARIHD,Hospital |
OPD
HOSPITAL
Room no 7 Khordha ORISSA |
9958355177 06742387702 drbhuyangc@gmail.com |
Dr Jeuti Rani Das |
RARIGID Hospital;Guwahati |
RARIGID Borsojai;
Beltola,Guwahati - Kamrup ASSAM |
9509192744 03612303714 djeutirani@yahoo.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 2 |
Name of Committee |
Approval Status |
Institutional Ethical Commitee,RARIGID,Guwahati |
Approved |
Institutional Ethical Committee ,CARIHD,Bhubaneswar |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K582||Mixed irritable bowel syndrome, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Mustakarista |
Dose : 25 ml twice daily with equal quantity of water
Dosage form : Arishta
Route of Administration : Oral
Time of Administration : Twice a day after food
Anupana : Water
Duration of therapy : 12 weeks
|
Comparator Agent |
Not Applicable |
Nil |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
Known cases of Grahani (diagnostic criteria as per classical Ayurvedic parameters)
Patients willing to give written informed consent to participate in the study
|
|
ExclusionCriteria |
Details |
1. Patients with history of Inflammatory Bowel Disease (IBD), Koch’s abdomen, Gluten intolerance.
2. Patients with history of chronic Amoebiasis.
3. Known cases of Diabetes Mellitus.
4. Patients with poorly controlled Hypertension ( >160/100 mmHg)
5. Patients who have history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months
6. Symptomatic patients with clinical evidence of Heart failure
7. Known cases of malignancy
8. Patients with concurrent serious hepatic disorders (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT) > 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).
9. Women who are planning for conception / pregnant or lactating.
10. H/o hypersensitivity to any of the trial drugs or their ingredients
11. Patients who have completed participation in any other clinical trial during the past three months
12. Any other condition which the Investigator thinks may jeopardize the study
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
|
Blinding/Masking
|
|
Primary Outcome
|
Outcome |
TimePoints |
To assess the clinical efficacy of Mustakarishta by the assessment of Changes in Ayurvedic Parameters of Grahani. |
Bseline,on 14th day, 28th day, 42th day, 56th day, 70th day,84th day,98th day |
|
Secondary Outcome
|
Outcome |
TimePoints |
To assess the clinical efficacy of Mustakarishta by the assessment of Changes in IBS-QOL score. |
Baseline,on 14th day, 28th day, 42th day, 56th day, 70th day,84th and 98th day |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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/ Phase 3 |
Date of First Enrollment (India)
|
26/09/2019 |
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="2" Months="0" Days="0" |
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)?
|
Brief Summary
|
According to Ayurveda “Rogaah
Sarvepi mandagnou sudaramudarani cha†means all the diseases
are caused by mandagni ((digestive fire or
various enzymatic process involved in digestion, absorption and metabolism at
various level) which causes improper digestion of ingested nutrients (food)
leading to formation or accumulation of Amadosha (intermediate
products/or toxins) which produces its effect locally or generalized) .Grahani
(middle part of amasaya and pakwasaya) is the place of Jatharagni.
When the digestive power of Grahani become weaken due to the improper food habits and stress
full life
style, It causes Grahani roga which is also known
as Grahani in Ayurveda. In general, the digestion and
absorption of food materials can be divided into 3 major phases: Luminal,
Mucosal and Post - absorptive phases. The luminal phase in which the
fats, proteins, and carbohydrates are hydrolyzed and solubilized by
secreted digestive enzymes and bile can be considered to be the role of Pachaka
Pitta which is responsible for the breakdown and synthesis of substances i.e.
catabolic and anabolic activities. Mucosal phase relies on the integrity of the
brush-border membrane of intestinal epithelial cells to transport digested
products from the lumen into the cells is compared to Kledaka Kapha
by the virtue of its cooling property
which counter the heating property of
Pitta. In modern medicine, the disease
can be co-related with malabsorption syndrome and also Irritable Bowel
Syndrome. There are enormous formulations mentioned in Ayurvedic classics for
the augmentation and restoration of Agnibala in general and Grahani
in particular. The Mustakarishta is a
reputed formulation, mentioned in the Bhaishajya Ratnavali, a
classical text of
Ayurveda for
the treatment of Ajirna,Agnimandya,Grahani, Visuchika etc.
As Grahani roga is caused due to
agnimandya, the main line of treatment is to correct the agnidusti by
administering drugs which are deepana and pachana in nature. The trial drug Mustakarishta is a classical medicine mentioned in Bhaishajya Ratnavali as well as AFI- Part-I, 1:26
(pg. 17) and API Part – II, Vol.II (1st
edition, pg. 45). The Ingredients contain in this trial medicine are having properties like deepan, pachana
and sthambhaka and can able to correct the agnimandya condition and
disorders of Purishavaha srotas.
So the aim and object of the present study is
planned to evaluate therapeutic efficacy of Mustakarishta
in the
patients of Grahani along with safety measures by observing adverse
events (AE) if any or Adverse drug reaction (ADR). The efficacy of the trial
drug would be assessed by observing the improvement in Subjective parameters
(Clinical Symptoms). Improvement in WHOQOL score and lab. parameters. |