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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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