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CTRI Number  CTRI/2025/09/095488 [Registered on: 30/09/2025] Trial Registered Prospectively
Last Modified On: 29/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Efficacy Of Homoeopathic Medicines In Treatment Of Lactose Intolerance 
Scientific Title of Study   Efficacy Of Individualized Homoeopathic Medicines In Treatment Of Lactose Intolerance - A Randomized Placebo Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  BANMEET KAUR 
Designation  PG SCHOLAR 
Affiliation  Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute 
Address  Room no. 102, Paediatrics Department Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute Tantia University Near RIICO Bus stand Hanumangarh Road Sri Ganganagar Ganganagar 335002 Rajasthan

Ganganagar
RAJASTHAN
335002
India 
Phone  9877401560  
Fax    
Email  banmeetkaur3@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Amritpal Singh 
Designation  Associate Professor , Paediatrics Department  
Affiliation  Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute 
Address  Tantia University Near RIICO Bus stand Hanumangarh Road Sri Ganganagar Ganganagar 335002 Rajasthan

Ganganagar
RAJASTHAN
335002
India 
Phone  9914930022   
Fax    
Email  docamritpalsinghmd@gmail.com  
 
Details of Contact Person
Public Query
 
Name  BANMEET KAUR 
Designation  PG SCHOLAR 
Affiliation  Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute 
Address  Room no. 102, Paediatrics department, Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute Tantia University Near RIICO Bus stand Hanumangarh Road Sri Ganganagar Ganganagar 335002 Rajasthan

Ganganagar
RAJASTHAN
335002
India 
Phone  9877401560  
Fax    
Email  banmeetkaur3@gmail.com  
 
Source of Monetary or Material Support  
Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute Tantia University Near RICCO Bus stand Hanumangarh road sri ganganagar Ganganagar 335002 Rajasthan 
 
Primary Sponsor  
Name  Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute 
Address  Tantia University Near RICCO Bus stand Hanumangarh road sri ganganagar Ganganagar 335002 Rajasthan 
Type of Sponsor  Research institution and hospital 
 
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 Banmeet Kaur  Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute  Room no. 102, Paediatrics Department, Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute Tantia University Near RIICO Bus stand Hanumangarh Road Sriganganagar Ganganagar 335002 Rajasthan
Ganganagar
RAJASTHAN 
9877401560

banmeetkaur3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sri Ganganagar Homoeopathic Medical College Hospital And Research Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E739||Lactose intolerance, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized Homoeopathic Medicine  the dose and repetition of medicines may vary according to the susceptibility and sensitivity of the patient. In this trial dosage and repetition will be as per the case and guidelines of organon of medicine. Route of administration- homoeopathic globules Duration- Minimum five follow- ups at the interval of 15 days (may vary according to clinical condition of patient) 
Comparator Agent  placebo  the patient will recieve placebo in homoeopathic globules. 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1 Clinically diagnosed patients with lactose intolerance
2 Age range- 5 to 12 years of age
3 Children of Both sexes
4 Willingness to participate- Patient’s parents willing to participate in the study and provide informed consent.
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in symptoms of lactose intolerance, such as abdominal pain, bloating, flatulence, nausea in patients receiving individualized homoeopathic treatment  Before final exams of part 2 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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   N/A 
Date of First Enrollment (India)   03/11/2025 
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)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Aim-

To evaluate the efficacy of individualized homoeopathic medicines in the treatment of lactose intolerance and their role in improving the quality of life of affected individuals.

Objectives-

To determine which homoeopathic medicine is most effective in treating lactose intolerance.

To monitor changes in Visual Analog Scale : Lactose-intolerance-related symptoms (VAS), Bristol stool scale after giving homoeopathic medicines.

Introduction: Lactose intolerance primarily refers to having different symptoms upon the consumption of foods containing lactose. It is one of the most common form of food intolerance and occurs when lactase activity is reduced in the brush border of the small bowel mucosa. Individuals may be lactose intolerant to varying degrees, depending on the severity of these symptoms. When lactose is    not digested, it can be fermented by gut microbiota leading to symptoms of lactose intolerance that include abdominal pain, bloating, flatulence, and diarrhea with a considerable intra-individual and inter-individual variability in the severity of clinical manifestations. Homoeopathy is a vital philosophy in that it interprets diseases and sickness as caused by disturbance in a vital force or life force.  Homoeopathic cure is mild, gentle, developed through growth, is dynamic in nature. This study aims to evaluate the efficacy of individualized homoeopathic medicines in managing lactose intolerance, adopting a holistic approach to address the manifestations of the condition.

Study Design : Randomized control trial –  Single blind method Randomization method – coin flip method

Heads-Group- A (treatment group ) , Tails – Group- B  (control group)  

Study procedure: The study begins with a target sample size of 92 children diagnosed with lactose intolerance. Each participant undergoes detailed case taking, which includes medical history, general physical examination, and confirmation of lactose intolerance as per ICD-10 diagnostic criteria. Once eligibility is confirmed based on inclusion and exclusion criteria, the participants are randomized into two groups of 46 each: one receiving individualized homoeopathic treatment and the other receiving a placebo. Prior to the initiation of treatment, baseline scoring is conducted using the Visual Analogue Scale (VAS) for lactose intolerance symptoms, the Bristol Stool Scale, and the KIDSCREEN-10 index to assess quality of life. Following this, the individualized treatment or placebo is administered according to group allocation. Participants are then followed up at intervals of 15 days, and at 1, 2, and 3 months—though this may vary depending on the patient’s clinical condition. At the end of the study, a final evaluation is conducted, including repeat case taking, physical examination, and reassessment of lactose intolerance 

 
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