| CTRI Number |
CTRI/2024/12/078301 [Registered on: 18/12/2024] Trial Registered Prospectively |
| Last Modified On: |
09/08/2026 |
| 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 treatment of indigestion in adults |
|
Scientific Title of Study
|
Efficacy of individualized homoeopathic medicines in the treatment of functional dyspepsia in adults: A double-blind, randomized, placebo-controlled trial using different homoeopathic repertories |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1316-1793 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Leishangthem Rajeshwori Devi |
| Designation |
Postgraduate Trainee |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Dept of Repertory, OPD room no. PG3 and PG5, 12, Gobinda Khatick Road
Kolkata
WEST BENGAL
700046
India |
| Phone |
6009071257 |
| Fax |
|
| Email |
rajeshwori.leishang@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjib Sarkar |
| Designation |
Reader and Head |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Anatomy, OPD room no. PG3, 12, Gobinda Khatick Road
Kolkata
WEST BENGAL
700046
India |
| Phone |
9903701819 |
| Fax |
|
| Email |
sanjibsarkar1102@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjib Sarkar |
| Designation |
Reader and Head |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Anatomy, OPD room no. PG3, 12, Gobinda Khatick Road
Kolkata
WEST BENGAL
700046
India |
| Phone |
9903701819 |
| Fax |
|
| Email |
sanjibsarkar1102@gmail.com |
|
|
Source of Monetary or Material Support
|
| D. N. De Homoeopathic Medical College and Hospital, 12 Gobinda Khatick Road, Kolkata-700046 |
|
|
Primary Sponsor
|
| Name |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
12 Gobinda Khatick Road, Kolkata-700046 |
| Type of Sponsor |
Government medical college |
|
|
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 Leishangthem Rajeshwori Devi |
D. N. De Homoeopathic Medical College and Hospital |
Dept of Repertory OPD no. PG3 and PG5, 12,Gobinda Khatick Road, Kolkata-700046
Kolkata
WEST BENGAL |
6009071257
rajeshwori.leishang@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of D. N. De Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K30||Functional dyspepsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical-looking placebo plus concomittant care |
A placebo that looks exactly like verum will be given to this arm. The quantity and frequency of the placebo depend on the specific needs of each patient. Each dose consists of four globules (no. 30) of cane sugar that have been moistened with rectified spirit and consumed orally on an empty stomach. Three months are allotted for therapy. The drugs and placebos will be repackaged in matching glass bottles, branded with the drugs name, potency, and code. Then, the drugs will be given in accordance with the random number list. ose: Individualized; Frequency: Individualized; Route of administration: Per oral; Duration of therapy: 3 months |
| Intervention |
Individualized homoeopathic medicines in individualized dosage plus concomittant care |
According to what is deemed appropriate for the case or condition, the intervention is designed to involve delivering indicated homeopathic medications at centesimal potencies. On a centesimal scale, a single dose consists of 30 cane sugar globules (no. 4) treated with the prescribed medication (kept in 90% v/v ethanol) and administered orally on an empty stomach. The quantity and frequency of administration are contingent upon the specific needs of each case. Patients will be instructed to suck the globules rather than swallow them, and they will be forbidden from handling the globules or from eating, drinking, smoking, or brushing their teeth for 30 minutes after ingesting them. Every medication will be purchased from a company accredited by Good Manufacturing Practices (GMP). The therapy lasted for three months. Every time, a single, individualized medication will be prescribed taking into account presenting totality of symptom, clinical history details, constitutional features, miasmatic expressions, repertorization using various repertories with the aid of Zomeo software in each case with due consultation of Materia Medica and due consensus among three homoeopaths. Based on the principles of classical homoeopathy, provisions will be made for changing the medications or potencies and alter the dosage in subsequent visits as needed and such instances will be compared between groups. Concomitant care measure includes diet plan. Dose: Individualized; Frequency: Individualized; Route of administration: Per oral; Duration of therapy: 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18-60 years
2. Participants of either sex or transgender
3. Diagnosed functional dyspepsia (ICD 11- DD90.3) as per ROME IV criteria. One or more of the following for the last 3 months with symptom onset at least 6 months prior to diagnosis:
a) Bothersome postprandial fullness.
b) Bothersome epigastric pain
c) Bothersome early satiation
d) Bothersome epigastric burning
And, no evidence of structural disease (at upper GI endoscopy) that is likely to explain the symptoms.
4. Patients who are already undergoing regular therapy for dyspeptic ailments, provided the medications are stopped completely at least 2 weeks prior study entry.
5. Providing written informed consent
6. Patients with ability to understand English/Bengali/Hindi. |
|
| ExclusionCriteria |
| Details |
1. Alarm symptoms of dyspepsia
a)Unintentional weight loss
b)Difficulty swallowing(dysphagia)
c)Painful swallowing(odynophagia)
d)Unexplained iron deficiency anemia
e)Persisting vomiting
f)Detectable mass or Lymphadenopathy
g)Family history of upper gastrointestinal cancer
2. Recent significant GI surgery within last 6 months.
3. Patients who are too sick for consultation.
4. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life.
5. Pregnancy, puerperium and lactation.
6. Substance abuse and/or dependence (TAPS TOOL)
7. Self-reported immune-compromised state, and
8. Undergoing homeopathic treatment for any chronic disease within last 3 months.
9. Unwilling to take part and not giving consent to join the study.
10. Simultaneous participation in any other clinical trial. |
|
|
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 |
| Patient Assessment of Upper Gastrointestinal Disorders Symptoms Questionnaire (PAGI-SYM) |
Baseline, and every month, up to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Short Form Nepean dyspepsia index (SF-NDI) |
Baseline, and every month, up to 3 months |
| Measure Yourself Medical Outcome Profile v.2 (MYMOP-2) |
Baseline, and every month, up to 3 months |
|
Target Sample Size
Modification(s)
|
Total Sample Size="117"
Sample Size from India="117"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="117" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [rajeshwori.leishang@gmail.com].
- For how long will this data be available start date provided 01-01-2027 and end date provided 31-12-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
Brief Summary
Modification(s)
|
This randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of individualized homeopathic medicines (IHMs) in 117 adults with Rome IV-defined functional dyspepsia (FD). Although IHMs did not demonstrate statistically significant superiority over placebo for the prespecified primary outcome, several secondary and exploratory analyses showed directionally favorable effects, while all findings remained appropriately interpreted in light of multiplicity and uncertainty. The trial incorporated rigorous allocation concealment and blinding procedures, validated patient-centered outcomes, baseline-adjusted and longitudinal analyses, extensive sensitivity analyses, and prospective assessment of safety and patient perspectives. The intervention was well tolerated, with no serious adverse events. We believe the study makes a valuable contribution by providing a methodologically rigorous assessment of an extensively used but insufficiently studied therapeutic approach and by identifying priorities for future adequately powered multicenter research in FD. |