| 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
|
|
|
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
|
|
|
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 |
|
|
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 |