| CTRI Number |
CTRI/2025/09/094857 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical evidence based comparison of LM and Centesimal potencies of Homoeopathic medicines in patients suffering with bronchial asthma by checking allergy marker IgE level. |
|
Scientific Title of Study
|
A Comparative Clinical Approach of Homoeopathic Medicine in LM potency and Centesimal potency in the Modulation of Serum IGE levels in patients with Bronchial Asthma |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saumya Srivastava |
| Designation |
PG SCHOLAR |
| Affiliation |
BVDUHMC |
| Address |
Bharati Vidyapeeth Deemed to be university Homoeopathic Medical College and Homoeopathic Hospital Department of Post graduate and research centre pune bangalore highway Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
7754905737 |
| Fax |
|
| Email |
saumya.srivastava-hmcpune@bvp.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Kakandikar |
| Designation |
MD(Hom) |
| Affiliation |
BVDUHMC |
| Address |
Bharati Vidyapeeth Deemed to be university Homoeopathic Medical College and Homoeopathic Hospital Department of Post graduate and research centre pune bangalore highway Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
8623889118 |
| Fax |
|
| Email |
poonam.kakandikar@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poonam Kakandikar |
| Designation |
MD(Hom) |
| Affiliation |
BVDUHMC |
| Address |
Bharati Vidyapeeth Deemed to be university Homoeopathic Medical College and Homoeopathic Hospital Department of Post graduate and research centre pune bangalore highway Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
8623889118 |
| Fax |
|
| Email |
poonam.kakandikar@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth Deemed to be university Homoeopathic Medical College and Homoeopathic Hospital Department of Post graduate and research centre pune bangalore highway Pune Maharashtra 411043 |
|
|
Primary Sponsor
|
| Name |
Dr Saumya Srivastava |
| Address |
Bharati Vidyapeeth Deemed to be university Homoeopathic Medical College and Homoeopathic Hospital Department of Post graduate and research centre pune bangalore highway Pune Maharashtra 411043 |
| Type of Sponsor |
Other [self] |
|
|
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 Saumya Srivastava |
BVDU Homoeopathic Medical College and Hospital, Dept of postgraduate and Research Centre, Pune |
Organon of Medicine and Homoeopathic Philosophy OPD,Department of Organon of medicine and homoeopathic philosophy, katraj,Dhankawadi,Pune 411043
Pune
MAHARASHTRA |
07754905737
saumya.srivastava-hmcpune@bvp.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Bharati Vidyapeeth (DTU) HMC Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J459||Other and unspecified asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Homoeopathic medicine in Centesimal Potency. |
Individualized homoeopathic remedies prescribed in Centesimal potency according to symptom similarity given orally in standard dose and repetition as per homoeopathic principles. Total duration of study is 18 months. |
| Intervention |
Homoeopathic Medicine in LM Potency. |
Individualized homoeopathic remedies prescribed in LM Potency according to symptom similarity, given orally in standard dose and repetition as per homoeopathic principles.Total duration of study is 18 months. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Cases of every age (except children below 6 years of age ) both genders and of different occupations have been included in the study |
|
| ExclusionCriteria |
| Details |
Patients with acute severe asthma or status asthmaticus,patients with cardiac,pulmonary or any other systemic diseases. Pregnant women,Patients who have not given consent for the study, patients with other respiratory ailments, patients with other atopic ailments which increases IgE level like atopic eczema,allergic rhinits. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Serum IgE levels in patients with Bronchial Asthma |
Assessed at baseline and after every 5 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To analyze the effect of homoeopathic medicine on the overall quality of life in patients with Bronchial Asthma |
Assessed at baseline and after every 5 months. |
| To observe the disease relation with the potency of LM and Centesimal potency. |
Assessed at baseline and after every 5 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/10/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Patients diagnosed with Bronchial asthma were selected based on inclusion and exclusion criteria. After obtaining informed consent, baseline data including demographic details, clinical history, serum IgE level, and the score of ACT(Asthma control test) / C-ACT (Childhood Asthma Control Test) questionnaire is recorded. By following case taking proforma, cases will be taken and the individualized homoeopathic medicine will be selected on the basis of simillimum. Patients divided into the groups will receive Homoeopathic medicine in LM potency and Centesimal potency, to compare the efficacy. Blood Analysis of IgE will be taken before the start of treatment and at the last follow up IgE Level will be tested again.
|