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CTRI Number  CTRI/2019/08/020607 [Registered on: 07/08/2019] Trial Registered Prospectively
Last Modified On: 06/08/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Jatiphaladi Churna and Chitrakadi Gutika in the treatment of Grahani (Irritable bowel Syndrome) 
Scientific Title of Study   Clinical Evaluation of Jatiphaladi Churna and Chitrakadi Gutika in the Management of Grahani 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Purnendu Panda  
Designation  Research Officer (Ayurveda) 
Affiliation  Centra Ayurveda Research Institute For Hepatobiliary Disorders, Bharatpur, Bhubaneswar 
Address  Central Ayurveda Research Institute For Hepatobiliary Disorders, Bharatpur, Bhubaneswar

Khordha
ORISSA
751029
India 
Phone  06742387702  
Fax  06742387702  
Email  pandapurnendu02@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Purnendu Panda 
Designation  Research (Ayurveda) 
Affiliation  Centra Ayurveda Research Institute For Hepatobiliary Disorders, Bharatpur, Bhubaneswar 
Address  Central Ayurveda Research Institute For Hepatobiliary Disorders, Bharatpur, Bhubaneswar

Khordha
ORISSA
751029
India 
Phone  06742387702  
Fax  06742387702  
Email  pandapurnendu02@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Purnendu Panda 
Designation  Research (Ayurveda) 
Affiliation  Centra Ayurveda Research Institute For Hepatobiliary Disorders, Bharatpur, Bhubaneswar 
Address  Centra Ayurveda Research Institute For Hepatobiliary Disorders, Bharatpur, Bhubaneswar

Khordha
ORISSA
751029
India 
Phone  06742387702  
Fax  06742387702  
Email  pandapurnendu02@yahoo.com  
 
Source of Monetary or Material Support  
Ministry of AYUSH, Govt of INDIA 
 
Primary Sponsor  
Name  CCRASNew Delhi 
Address  Institutional area,Opposite D Block , Janakpuri, New Delhi 
Type of Sponsor  Other [An autonomous research organisation 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 
Dr Purnendu Panda  CARIHD HOSPITAL Bhubaneswar  Hospital Division ,Central Ayurveda Research Institute For Hepatobiliary Disorders, Bharatpur Bhubaneswar
Khordha
ORISSA 
9777852889
06742387702
pandapurnendu02@yahoo.com 
Dr M N Suryawanshi  RARIGID HOSPITAL, Guwahati  Hospital division,REGIONAL AYURVEDA RESEARCH INSTITUTE FOR GASTRO-INTESTINAL DISORDER Borsojai, Beltola, Guwahati-781028. Kamrup ASSAM
Kamrup
ASSAM 
8329875011
03612303714
anvay.ojas2006@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethical Committee, CARIHD, Bhubaneswar  Approved 
Institutional Ethical Committee, RARIGID,Guwahati  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  1. Jatiphaladi Churna   Dose: 2gm twice daily Dosage form: Churna (powder) Route of Administration : Oral Time of Administration : Twice a day after food Anupana : Water Duration of therapy 12 weeks  
Intervention  2.Chitrakadi Gutika   2.Dose: 500mg (one tab) twice daily Dosage form Vati (Pill/Tablet) 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  1. Patients of either sex aged 18-65 years
2. Known cases of Grahani (diagnostic criteria as per classical Ayurvedic Parameters) with following symptoms
3. Patients willing to give written informed consent and able to participate for 3 months.
 
 
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    
Method of Concealment    
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the clinical efficacy of Jatiphaladya Churna & Chitrakadi Gutika by the assessment of Changes in Ayurvedic Parameters of Grahani

 
Base line , At the end of 14th day, 28th day, 42nd day, 56th day, and 70th day, 84th day and 98th day.

 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the clinical efficacy of Jatiphaladya Churna & Chitrakadi Gutika by the assessment of Changes in IBS-QOL score  Base line , At the end of 14th day, 28th day, 42nd day, 56th day, and 70th day, 84th day 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)   21/08/2019 
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 Sarvepimandagou” means all the diseases are caused by mandagin ((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 Jatharagin. When the digestive power of grahani became less due to the improper food habits and stressfull life style. It causes Grahani roga which is 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 di fats, proteins, and carbohydrates are hydrolyzed and solubilised 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.Jatiphaladya Churna & Chitrakadi gutika are reputed formula, though mentioned in the Sarangadhara Samhita and Charaka Samhita respectively in Ayrveda classics, for the treatment of Grahani, Atisara, Agnimandya 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 action. The trial durgs like Jatiphaladi Churna and Chitrakadi Gutika are  classical medicines formulated by Achary Charak and Acharya Sarangadhara.Which are referred to AFI,Part-I, 7:12. and AFI,Part-I, 12:11. The Ingredients which these trial medicines are  contains, having properties like deepan, pachana and sthambhaka and can able to correct the agnimandya condition and disordered of purishavaha stoats.

      So  the aim and object of the present study is planned to evaluate therapeutic efficacy of Jatiphaladi Churna and Chitrakadi Gutika in the patients of Grahani along with safety measures by observing adverse events (AE) if any or Adverse drug reaction (ADR). The efficacy of these drugs would be assessed by observing the improvement in Subjective parameters (Clinical Symptoms). Improvement in WHOQOL score and lab parameters.

 
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