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CTRI Number  CTRI/2021/08/036044 [Registered on: 31/08/2021] Trial Registered Prospectively
Last Modified On: 27/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Homeopathic medicines in dyspepsia 
Scientific Title of Study   Double-blind, randomized, placebo-controlled trial of individualized homeopathic medicines in 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  Dr Gurudev Choubey 
Designation  Research Officer(Homeopathy) Scientist 3 
Affiliation  Central Council for Research in Homoeopathy 
Address  Clinical Research Unit for Homeopathy, under CCRH, Research OPD -1 Arabindopally, Siliguri
Monoarama Apartment Gokhel Road Arabindopally Siliguri Darjeeling
Darjiling
WEST BENGAL
734006
India 
Phone  9475916907  
Fax    
Email  gurudev.choubey@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Charanjeet singh 
Designation  Principal 
Affiliation  SriGanganagar Homepathic medical college and Research centre 
Address  Department of Materia Medica, Tantia University Campus Hanumangarh Road Near RIICO Busstand Sri Ganganagar Rajasthan
Tantia University Campus Hanumangarh Road Near RIICO Busstand Sri Ganganagar Rajasthan
Ganganagar
RAJASTHAN
335002
India 
Phone  9414225433  
Fax    
Email  sgnhh@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Charanjeet singh 
Designation  Principal 
Affiliation  SriGanganagar Homepathic medical college and Research centre 
Address  Department of Materia medica,Tantia University Campus Hanumangarh Road Near RIICO Busstand Sri Ganganagar Rajasthan
Tantia University Campus Hanumangarh Road Near RIICO Busstand Sri Ganganagar Rajasthan
Ganganagar
RAJASTHAN
335002
India 
Phone  9414225433  
Fax    
Email  sgnhh@yahoo.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Gurudev Choubey 
Address  Monoarama Apartment,Gokhel Road,Arabindopally,Siliguri Darjeeling 
Type of Sponsor  Other [Independent Reseacher] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gurudev Choubey  Clinical Research Unit for Homeopathy,Siliguri  Research OPD -1, Research Division CRU(H) Gokhel road,Arabindopally,Siliguri
Darjiling
WEST BENGAL 		 7908955160

gurudev.choubey@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K30||Functional dyspepsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualised homeopathic medicine  Dose-Intervention is planned as administering indicated homoeopathic medicines in centesimal potencies, as decided appropriate to the case or condition. Route of administration and frequency - In centesimal scale, each dose shall consist of 4 globules (no. 30) of cane sugar, medicated with the indicated medicine (preserved in 90% v/v ethanol) to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases”. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking or brushing teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. “All medicines will be procured from a Good Manufacturing Practice (GMP)-certified firm. Duration-5 to 30 days depending on potency  
Comparator Agent  Placebo  Dose and frequency-This arm will receive placebo, indistinguishable in appearance from verum. Route of administration-Each dose of placebo shall consist of 4 globules (no. 30) of cane sugar, moistened with rectified spirit, to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Functional dyspepsia (ICD-10-CM Diagnosis Code K30) as per the Rome IV criteria
2.. “Patients already undergoing regular therapy for dyspeptic ailments, provided the medications are stopped completely at least 2 weeks prior study entry”
3.. “Literate patients; ability to read Bengali and/or English”
4. Providing written informed consent
 
 
ExclusionCriteria 
Details  1. Recent significant GI surgery within last 6 months
2. Patients who are too sick for consultation
3. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life
4. Pregnancy, puerperium and lactation
5. Substance abuse and/or dependence
6. Self-reported immune-compromised state, and
7. Undergoing homeopathic treatment for any chronic disease within last 6 months.
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Leeds Dyspepsia Questionnaire - Short Form (LDQ-SF)  Baseline, every month, up to 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Frequency of use of standard conventional drugs for functional dyspepsia during study period of 3 months  Baseline, every month, up to 3 months 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
Final Enrollment numbers achieved (Total)= "140"
Final Enrollment numbers achieved (India)="140" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/09/2021 
Date of Study Completion (India) 01/02/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 None yet; to be published in Good peer-reviewed journal 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 Functional dyspepsia (FD) is a clinical syndrome characterized by chronic or recurrent upper abdominal pain or discomfort with no identifiable cause. Symptoms should be present for a minimum of 3 months; however, symptoms lasting greater than 6 months are typical. This disorder is not a mono-symptomatic entity; several predominant symptoms may be present, including epigastric pain (22%), abdominal fullness (24%), bloating (15%), vomiting (3%), belching (8%), early satiety (12%), nausea (10%), and heartburn (6%). Individuals with functional dyspepsia suffer significant morbidity and expend significant resources through both direct and indirect costs. The prevalence of FD is estimated to be 11.5-14.7%. A double-blind, randomized, placebo-controlled, two parallel arms clinical trial was conducted on 140 patients (70 in each group) suffering from FD at the outpatient department of Clinical Research Unit (Homoeopathy), Siliguri, under Central Council for Research in Homoeopathy, Ministry of AYUSH, Govt. of India; Gokhel Road, Arabindopally, Siliguri, Pin 734006, West Bengal. Patients were randomized in 1:1 ratio into either individualized homeopathic medicinal products (IHMPs) or identical-looking placebo. Outcome measures (primary – Leeds dyspepsia questionnaire – short form; secondary - frequency of use of standard conventional drugs for functional dyspepsia during study period of 3 months) were recorded at baseline, and every month, up to 3 months. The attrition rate was 9.3%. Group differences favored IHMPs against placebos in all the outcomes (LDQ-SF total: P < 0.001; LDQ-SF symptom frequency: P < 0.001; LDQ-SF symptom severity: P < 0.001, number of participants consuming antacids: P = 0.001; and the number of antacids consumed: P < 0.001), with large effect sizes. Nux vomica (18.6%), Sulphur (15%), Lycopodium clavatum (12.1%), Pulsatilla nigricans (6.4%), and Carbo vegetabilis (5%) were the most frequently prescribed remedies. IHMPs acted significantly better than placebos in the treatment of FD. Independent replications are required to validate the findings. 
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