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CTRI Number  CTRI/2024/12/078029 [Registered on: 12/12/2024] Trial Registered Prospectively
Last Modified On: 10/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Homeopathic Asthma Trial 
Scientific Title of Study   A 29 week randomised, double-blind, placebo controlled, parallel design, single centred phase 2 study to assess the efficacy of individualised homoeopathic treatment as add on therapy in management of asthma in atopic or non-atopic subjects. 
Trial Acronym  HAT_21 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jignya Shah 
Designation  Principal Investigator 
Affiliation  Holistic Health Foundation 
Address  13, Sunflower Raw Houses, Opposite Jarimari Mata Mandir, Old Poloce Lane, Kharkar Ali, Thane West
706/J Wing, Bhoomi Acres, Phase #2, Waghhbil, G B Road, Thane West
Thane
MAHARASHTRA
400601
India 
Phone  9867932236  
Fax    
Email  jignya_shah@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jignya Shah 
Designation  Principal Investigator 
Affiliation  Holistic Health Foundation 
Address  13, Sunflower Raw Houses, Opposite Jarimari Mata Mandir, Old Poloce Lane, Kharkar Ali, Thane West
706/J Wing, Bhoomi Acres, Phase #2, Waghhbil, G B Road, Thane West
Thane
MAHARASHTRA
400601
India 
Phone  9867932236  
Fax    
Email  jignya_shah@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Jignya Shah 
Designation  Principal Investigator 
Affiliation  Holistic Health Foundation 
Address  13, Sunflower Raw Houses, Opposite Jarimari Mata Mandir, Old Poloce Lane, Kharkar Ali, Thane West
706/J Wing, Bhoomi Acres, Phase #2, Waghhbil, G B Road, Thane West
Thane
MAHARASHTRA
400601
India 
Phone  9867932236  
Fax    
Email  jignya_shah@yahoo.com  
 
Source of Monetary or Material Support  
Ministry of Ayush Through Central Council of Homeopathy, D Block Janakpuri Institutional AreaNew Delhi, Delhi 110058  
 
Primary Sponsor  
Name  Ministry of AYUSH Through CCRH 
Address  61-65, Industrial Area, Opposite D Block, JanakPuri, New Delhi, Delhi 110058 
Type of Sponsor  Government funding agency 
 
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 Jignya Shah  Aryan Hospital  Ground floor, Creek View Apartments II, Kalwa naka, Kalwa, Thane-400605, Maharashtra, India
Thane
MAHARASHTRA 		 9867932236

jignya_shah@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vedant Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J452||Mild intermittent asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1)Individualised Homeopathic Medicine 2) Standard of   All the subjects will be treated with Standard of Care asthma treatment as per GINA 2023 guidelines throughout the trial period. Standard of Care Treatment step required will be documented before starting the treatment. Additionally, subjects shall receive either homoeopathic placebo or Individualised homoeopathic medicine depending upon the treatment group it falls into. An individualised homoeopathic medicine will be selected for each patient. PI shall be responsible for selection of individualised medicine after a detailed homoeopathic case taking which shall record details of asthma, its modalities, and concomitants in detail. PI shall also record details of physical general symptoms including thirst, appetite, craving, aversion, bowel, urine, perspiration, sleep etc. PI will note a brief account of patient’s personality, past history, etc. Homoeopathic medicines will be selected on the "principle of individualisation" as mentioned by Dr Hahnemann in the 6th edition of Organon of medicine. Homoeopathic pharmaceutical products prepared by mixing more than one potentised homoeopathic dilutions will not be used for the trial. Subjects shall consume 4pills from 1/2 –dram bottle for initial 2 das orally on clean tongue twice daily. From the next 26 days’ subject shall consume 4 pills from the 2-deram bottle twice daily.a drop of appropriate dilution of liquid potency will be used to medicate 1/2-dram bottle containing 40 number globules. Additionally, 2-dram plastic bottle containing 40 number globules medicated with placebo liquid shall be given to each subject. Subjects shall consume 4pills from 1/2 –dram bottle for initial 2 das orally on clean tongue twice daily. From the next 26 days’ subject shall consume 4 pills from the 2-deram bottle twice daily. 
Comparator Agent  Homeopathic placebo  Homeopathic placebo liquid containing low concentration alcohol procured from GMP certified pharmaceutical company shall be used for the trial. one 1/2 dram and one 2-dram plastic bottle containing 40 number globules medicated with placebo liquid shall be given to each subject. Subjects shall consume 4pills from 1/2 –dram bottle for initial 2 das orally on clean tongue twice daily. From the next 26 days’ subject shall consume 4 pills from the 2-deram bottle twice daily. 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Properly completed patient informed consent
2. Male or female and transgender aged at least 18 years /Children above 12 years can be included
3. Clinical history consistent with asthma.
4. Diagnosed asthmatics who may or may not be receiving treatment shall be inclusive.
5.Willingness and ability to sign ethics committee approved Informed Consent Form shall be inclusive. In case of illiterate subjects signature of an LAR shall be acceptable.
 
 
ExclusionCriteria 
Details  1) Infants and children below age of 12 years shall not be eligible.
2) Pregnant and nursing women shall be excluded.
3) Subjects having a history or symptoms of viral infection with in past 1 week shall be excluded.
4) Subjects having an acute exacerbation of asthma within 4 weeks shall be excluded for spirometry.
5) Subjects requiring oral corticosteroids shall be excluded.
6) Subjects not withholding prohibited drugs for the specified time period shall be excluded.
7)Subjects suffering from life threatening diseases will be excluded.
8) Subjects having a history of near fatal asthma requiring intubation and mechanical ventilation will be excluded.
9) subjects with history of hospitalisation for asthma in past 1 year will be excluded.
10) Subjects having history of anaphylactic reaction in the past will be excluded.
11) Subjects taking any homoeopathic therapy or preparation in any form shall be excluded.
12) Asthmatic with food allergy as a trigger for asthma will be excluded.
13) Subjects with COPD shall be excluded.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
1) The change in mean overall AQLQ score from base line in 28 weeks
2) The change in FEV1 from base line in 28 weeks
 		 1)Baseline data -Before Randomozation
2) Interim analysis - at the end of week 12
3) Final analysis - at the time of study completion or withdrawal 
 
Secondary Outcome  
Outcome  TimePoints 
1)Decrease in Total serum IgE level from baseline till the end of 28 weeks in subjects with raised total IgE levels at base line.
2) Decrease in AEC from baseline to end of 28 weeks in subjects with raised AEC at the baseline
3) Decrease in Sputum eosinophils count from baseline till end of 28 weeks in subjects with raised Sputum eosinophils count at the baseline. 		 1)Baseline data -Before Randomozation
2) Interim analysis - at the end of week 12
3) Final analysis - at the time of study completion or withdrawal 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 2 
Date of First Enrollment (India)   22/02/2025 
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 Applicable 
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  

PROTOCOL SYNOPSIS

 

Title of the project

A 29 week randomised, double-blind, placebo controlled, parallel design, single centred phase 2 study to assess the efficacy of individualised homoeopathic treatment as add on therapy in management of asthma in atopic or non-atopic subjects.

Phase of the trial

Phase 2

Indication

To be administered as an add on therapy to the standard of care asthma therapy (SOCAT) based on GINA report 2021 in asthmatic subjects who are atopic or non-atopic

Study Objectives

Primary objective:

To determine if addition of individualised homoeopathic medicine to the standard of care asthma treatment in atopic and non-atopic subjects who have asthma is useful in asthma management measured by

1) Better asthma related quality of life,

2)Better lung function as compared with standard of care asthma treatment alone in 28 weeks.

Secondary Objective:

To determine if addition of individualised homoeopathic medicine to the standard of care asthma treatment in atopic and non-atopic subjects who have asthma is associated with improvement in atopic status measured by decreased

1)  Total serum IgE levels,

2) Decreased AEC,

3) Decreased sputum eosinophils count

Study Design

This is a randomised, double blind, placebo-controlled, parallel, single centred phase 2 trial to evaluate the efficacy of individualised homoeopathic medicine as an add on therapy in asthmatic subjects with or without atopy.

Approximately 60 subjects will be enrolled, 30 on each arm. Eligible mild to moderate asthma patients with documented allergy will be enrolled. This trial consists of 4 stages 1) screening,2) Randomization,3) treatment,4) follow up. During screening phase each patient will provide informed consent prior to randomization.

 

After collection of baseline data patients will be randomised on homoeopathic medicines arm or homoeopathic placebo arm in the ration of 1:1 for a period of 24 weeks.

The randomization of subjects to study groups will be based on a randomization scheme that will be reviewed and approved by an independent statistician.

Both the arms shall receive standard of care asthma therapy based on GINA report 2021 for a period of 24 weeks. The expected duration of trial participation is 29 weeks.

Study end points

primary endpoint:

1) The change in mean overall AQLQ score from base line in 28 weeks

2) The change in FEV1 from base line in 28 weeks

 

Secondary endpoints:

1) Percentage of atopic subjects showing improvement in the atopic status demonstrated by total serum IgE level from baseline till the end of 28 weeks.

2) Percentage of subjects who had raised AEC at the baseline and show decrease in AEC from baseline to end of 28 weeks

3) Percentage of subjects who had raised Sputum eosinophils count at baseline showing decrease in Sputum eosinophils count from baseline till end of 28 weeks.

 

Safety endpoints:

1) ACT

2) Total Number of Adverse Events

3) PEF readings

4) Abnormal Physical Examination Finding

5) Abnormal Vital sign values

6) Abnormal ECG findings

7) Clinically Significant Abnormal laboratory findings

 

Study treatment

Test arm:

1) Standard of care asthma treatment as defined by GINA guidelines 2021                          

2) Orally administered centesimal/ LM potencies of Individualised homoeopathic medicines in globule and/or liquid OD dose for 24 weeks

Control arm:

1) Standard of care asthma treatment as defined by GINA guidelines 2021                

2) Orally administered globules or liquid homoeopathic placebo in OD dose for 24 weeks


Inclusion criteria

1. Properly completed patient informed consent

2. Male or female aged at least 18 years /Children above 12 years can be included

3. Clinical history consistent with asthma.

4. Diagnosed asthmatics who may or may not be receiving treatment shall be inclusive.

5.Willingness and ability to sign ethics committee approved Informed Consent Form shall be inclusive. In case of illiterate subjects signature of an LAR shall be acceptable.

Exclusion criteria

1) Infants and children below age of 12 years shall not be eligible.

2) Pregnant and nursing women shall be excluded.

3) Subjects having a history or symptoms of viral infection with in past 1 week shall be excluded.

4) Subjects having an acute exacerbation of asthma within 4 weeks shall be excluded for spirometry.

5) Subjects requiring oral corticosteroids shall be excluded.

6) Subjects not withholding prohibited drugs for the specified time period shall be excluded.

7)Subjects suffering from life threatening diseases will be excluded.

8) Subjects having a history of near fatal asthma requiring intubation and mechanical ventilation will be excluded.

9) subjects with history of hospitalisation for asthma in past 1 year will be excluded.

10) Subjects having history of anaphylactic reaction in the past will be excluded.

11) Subjects taking any homoeopathic therapy or preparation in any form shall be excluded.

12) Asthmatic with food allergy as a trigger for asthma will be excluded.

13) Subjects with COPD shall be excluded.

Sample size

 

Considering approximately 10% drop-out, in total 60 patients will be enrolled for the study in order to get 50 evaluable patients. A total of 60 patients will be randomized to one of 2 treatment groups in ratio of 1:1 (i.e., 30 patients per treatment group) so as to have 27 evaluable patients per treatment group i.e, completing the primary analysis (end of week 29) visit in the trial.


Statistical Analysis

Unless otherwise stated, all hypotheses will be tested at a significance level of 0.05 and 95% confidence interval. Data will be analyzed using R software version 4.0 or higher with appropriate statistical tests. The descriptive statistics for continuous variables will be presented with the number of subjects (n), mean, standard deviation (SD), median, minimum, and maximum value. For categorical data, the descriptive statistics will be presented with frequency (count and percent) of subjects falling within the category. Descriptive analyses will also include graphical presentations of data, wherever appropriate. The p-values will be displayed. The Statistical analysis plan will contain a more comprehensive explanation than described above of the methodology used in the statistical analyses. The Statistical analysis plan will also contain the rules and data handling conventions used to perform the analyses, and the procedure used for accounting for missing data.

 

 

 
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