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CTRI Number  CTRI/2021/09/036266 [Registered on: 06/09/2021] Trial Registered Prospectively
Last Modified On: 09/11/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Dizester a Herbal formulation for dyspepsia 
Scientific Title of Study   An open-label clinical study to evaluate the efficacy and safety of Dizester® Herbal in Patients suffering from functional dyspepsia. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Debasish Hota 
Designation  Professor 
Affiliation  AIIMS Bhubaneswar 
Address  Department of Pharmacology AIIMS Bhubaneswar
Department of Gastroenterology AIIMS Bhubaneswar 751019
Khordha
ORISSA
751019
India 
Phone  9438884190  
Fax    
Email  pharm_debasish@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Debasish Hota 
Designation  Professor 
Affiliation  AIIMS Bhubaneswar 
Address  Room No 115 Department of Pharmacology Academic Block AIIMS Bhubaneswar
Department of Pharmacology AIIMS Bhubaneswar
Khordha
ORISSA
751019
India 
Phone  9438884190  
Fax    
Email  pharm_debasish@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Manas Kumar Panigrahi 
Designation  Associate Professor 
Affiliation  AIIMS Bhubaneswar 
Address  Room No 223 OPD Block Department of Gastroenterology AIIMS Bhubaneswar
Room No 223 OPD Block Department of Gastroenterology AIIMS Bhubaneswar
Khordha
ORISSA
751019
India 
Phone  9438884190  
Fax    
Email  medgast_manas@aiimsbhubaneswar.edu.in  
 
Source of Monetary or Material Support  
Dr Willmar Schwabe India Pvt Ltd (sponsor) 
 
Primary Sponsor  
Name  Dr Willmar Schwabe India Pvt Ltd 
Address  A 36 Phase III Sector 60 Noida 201304 Uttar Pradesh India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manas Kumar Panigrahi  Department of Gastroenterology  Room No. 223 OPD Block AIIMS Bubaneswar Bhubaneswar 751019
Khordha
ORISSA 		 9438884267

medgast_manas@aiimsbhubaneswar.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee AIIMS Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K30||Functional dyspepsia. Ayurveda Condition: Dyspepsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dizester Herbal liquid  Five to ten ml to be taken orally two to three times a day 
Comparator Agent  Matched placebo liquid  Five to ten ml to be taken orally two to three times a day 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients in the age group between 18 to 65
years of either sex.
2. Patients able to provide informed consent.
3. Subject fulfilling the Rome IV criteria for functional dyspepsia which
includes one or more of the following

• Bothersome postprandial fullness
• Bothersome early satiation
• Bothersome epigastric pain
• Bothersome epigastric burning and
• No evidence of structural diseases (including the upper endoscopy) that
is likely to explain the symptoms
• Must fulfill criteria for Postprandial Distress Syndrome and or
Epigastric Pain Syndrome.
• Criteria fulfilled for the last 3 months with symptom onset at least 6
months before diagnosis.

4. Patients will included on the basis of signs and symptoms of Non ulcer dyspepsia, epigastric pain, burning sensation over epigastrium/ retrosternal region, sour, bitter eructation, nausea, vomiting, indigestion and abdominal distension.
 
 
ExclusionCriteria 
Details  1. Patients on Proton pump inhibitors
2. Pregnant or lactating women or with infants less than 1 year
3. Any preexisting condition or contraindications like CAD, abnormal creatinine levels, liver
dysfunction.
4. Patients with alarm features like unintentional weight loss, recurrent vomiting, dysphagia,
hemetemesis, melena, fever, jaundice, or anemia
5. Any kind of organic lesion such as peptic ulcer, tumor of any kind, stricture, or structural
deformity.
6. A previous endoscopic diagnosis of erosive gastroesophagitis or Barretts esophagus
7. Subject with known history of gastric bleeding, intestinal obstruction or perforation, and
previous gastrointestinal surgery.
8. Subjects with major systemic illness including cardiac disease, liver disease, kidney
disease, diabetes, hypertension, psychoneuroendocrinal disorders
9. Smoking or drug addicts or with psychiatric illness.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary End point
Improvement in symptoms on Reflux Disease Questionnaire
 		 Days 0 and 7 and 14 
 
Secondary Outcome  
Outcome  TimePoints 
• Improvement in The Short Form Leeds Dyspepsia Questionnaire
• Improvement GERD Health Related Quality of Life Questionnaire
• Improvement in visual analogue scale for pain
• Improvement in Investigators Assessment Symptomatic
• Changes in liver and renal function
• Changes in hemogram hemoglobin, total leukocyte count and differential count 		 Days 0 and 7 and 14 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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 3/ Phase 4 
Date of First Enrollment (India)   15/09/2021 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   After the study is completed, the data will be analysed by a qualified statistician and the manuscript will be submitted in a reputed scientific journal for publications 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response (Others) -  NIL

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response (Others) -  NIL
  3. Who will be able to view these files?
    Response (Others) -  NIL

  4. For what types of analyses will this data be available?
    Response (Others) -  NIL

  5. By what mechanism will data be made available?
    Response (Others) -  On personal request to the PI via email

  6. For how long will this data be available start date provided 15-09-2022 and end date provided 15-09-2026?
    Response (Others) -  NIL

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Introduction and background

Functional dyspepsia is defined as “the presence of epigastric burning, continual epigastric pain, postprandial fullness or early satiety in the absence of apparent organic disease”­ affecting significant population worldwide. Gastric acid hyper secretion is one of the probable causes of dyspepsia. Dizester® herbal is a poly herbal, formulation containing various clinically proven plant ingredients possessing antispasmodic, carminative and appetite stimulant properties. Its components are traditionally used for the management of hyper acidity, dyspepsia and various GI disorders. It also works as diuretic, anti-inflammatory, and protective against gastric mucosal lesion. However, its efficacy and safety were not evaluated in a randomised trial. Hence, the present study is planned to evaluate the efficacy and safety of Dizester® in patients suffering from functional dyspepsia.

Study Objectives

       i.           To evaluate efficacy of Dizester® herbal formulation in patients suffering from functionaldyspepsia.

      ii.           To evaluate safety of the investigational product.

Endpoints

  • Improvement in symptoms on Reflux Disease Questionnaire
  • Improvement in The Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ)
  • Improvement GERD-Health Related Quality of Life Questionnaire
  • Improvement in visual analogue scale (VAS) for pain
  • Improvement in Investigators Assessment Symptomatic
  • Changes in liver and renal function
  • Changes in hemogram (Hb, TLC, DLC)

 

Description of study design

This will be an open labelled, randomized placebo controlled study in patients suffering from functional dyspepsia. The study will be carried out at All India Institute of Medical Sciences, Bhubaneshwar, Odisha. The patients will be screened for eligibility and eligible subjects will be evaluated on days 0,7 and 14. for 4 weeks a with an expected study duration of 6-8 months.

After baseline assessment, the eligible participants who give written consent will be enrolled for the study. The enrolled patients will receive Dizester® Herbal as per dosing schedule. Patient data will be recorded in individual Case Record Form (CRF) at baselines, after two weeks and four weeks. Counselling sessions for informed consent process will be done face to face. Laboratory investigations will be done at baseline as well as at the end of the treatment.

 

STATISTICS

Sample size - The study will be conducted on 80 subjects suffering from functional dyspepsia

Statistical methods - Data will be entered into the Microsoft Excel and analyzed in the Statistical Package for the Social Sciences software (version 19.0, IBM SPSS). Primary endpoint, SF-LDQ, GERD-HRQOL, VAS will be analysed using t-test. Improvement in Investigators Assessment Symptomatic and adverse drug events will be analysed using chi-square test. p value < 0.05 will be considered statistically significant.

Analysis Sets - Two populations will be considered for the analysis: The intention-to-treat (ITT) population, per protocol (PP).

  1. Intention-to-treat (ITT) Population - ITT population for treatment effects including all subjects having received IP at least once and having at least one measurement of one of the treatment effect parameters during the treatment period.
  2. Per-protocol (PP) population - PP population will include those subjects of the full analysis set without major protocol deviation to protocol violations.

 

 
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