| CTRI Number |
CTRI/2025/09/095123 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Studying the effect of mineral-based medicines on patients with bronchial asthma using a symptom score |
|
Scientific Title of Study
|
Exploring the efficacy of mineral group remedies in case of bronchial asthma by using Lara Asthma Symptom Scale ( LASS ) : A prospective study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Adhvaryu Rinkal Chetanbhai |
| Designation |
MD Scholar |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
B 301 Shankheshwar 3 appartment begind Nageshwar jain temple Jamnagar Road Rajkot
Room no 101 Medicine OPD Gondal road Near makkam chowk Udhyog nagar colony Bhaktinagar Rajkot 360002
Rajkot
GUJARAT
360006
India |
| Phone |
7698895025 |
| Fax |
|
| Email |
rinkal.adhvaryu@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hitarth Mehta |
| Designation |
B.H.M.S , M.D ( HOM ) |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
A 32 Oscar residency 150 feet ring road b/h sterling hospital rajkot
ROOM NO 101 Medicine OPD Gondal road Near makkam chowk Udhyog nagar colony Bhaktinagar Rajkot 360002
Rajkot
GUJARAT
360007
India |
| Phone |
9825340073 |
| Fax |
|
| Email |
hitarth.mehtarhmc@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Adhvaryu Rinkal Chetanbhai |
| Designation |
MD SCHOLAR |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
B 301 Shankheshwar 3 appartment Behind nageshwar jain temple Jamnagar road Rajkot
Room no 101 Medicine OPD Gondal road Near Makkam chowk Udhyog nagar coloy Bhaktinagar Rajkot 360002
Rajkot
GUJARAT
360006
India |
| Phone |
7698895025 |
| Fax |
|
| Email |
rinkal.adhvaryu@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Rajkot Homoeopathic Medical College gondal road Near makkam chowk Udhyog nagar colony Bhaktinagar Rajkot |
|
|
Primary Sponsor
|
| Name |
Sainath Hospital |
| Address |
101 Gondal road Near Makkam chowk Udhyog nagar colony Bhaktinagar Rajkot 360002 |
| Type of Sponsor |
Private 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 Adhvaryu Rinkal Chetanbhai |
Sainath Homoeopathic Hospital |
Room no 101 Sainath Hospital Gondal Road near makkam chowk udhyog nagar colony bhaktinagar rajkot 360002
Rajkot
GUJARAT |
7698895025
rinkal.adhvaryu@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH - RAJKOT HOMOEOPATHIC MEDICAL COLLEGE [ RHMC ] , PARUL UNIVERSITY , GUJARAT |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J454||Moderate persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Exploring the Efficacy Of Mineral Group Remedies In Case Of Bronchial Asthma By using Lara Asthma Symptom Scale ( LASS ) : A Prospective study |
This study aims to evaluate the effect of Homoeopathic Mineral Group Remedies in patients suffering from Bronchial Asthma . The improving will be assessed using the Lara Asthma Symptom Scale (LASS), which records changes in breathing difficulty, cough and overall asthma symptoms.Patients will be followed over time to observe symptom relief and better quality of life with Homoeopathic treatment. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnostic Criteria were mainly based on Clinical history , presentation of complain and Laboratory Examination Findings .
2.Diagnosed case under treatment , want to shift towards Homoeopathy by consent .
3.Specific Age : Age between 15 – 45 years
4.Sex : both the sexes
5.Exacerbation History within the last 3-12 months .
|
|
| ExclusionCriteria |
| Details |
1.Other Respiratory disease condition like COPD , Interstitial lung Disease , Cystic fibrosis of lung .
2.Recent sever exacerbation – History of Severe Asthma , ICU admit in past 4 to 6 weeks , for Asthma last 4 weeks .
3.Other Major diseases like CVS , DM , CNS , Malignant and Autoimmune Diseases
4.Recent Respiratory Infection like Pneumonia , TB in last 4 months .
5.Pregnant and Lactating Woman
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of mineral group remedies in case of bronchial asthma |
AROUND 3 TO 6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in LASS Score Towards 0 |
Around 3 to 6 Months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
06/10/2025 |
| 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="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
|
Asthma is a chronic inflammatory respiratory disease causing cough, wheezing, breathlessness, and chest tightness. It is a major global health problem, often underdiagnosed and undertreated, contributing significantly to disability and reduced quality of life. Conventional treatments control symptoms but have limitations and side effects.
Homoeopathy offers individualized treatment, and mineral group remedies are considered especially useful in chronic conditions like bronchial asthma due to their deep and long-acting nature. Remedies such as Arsenicum album, Antimonium tartaricum, Natrum sulphuricum, Kali carbonicum, and others are frequently indicated.
This prospective clinical study aims to evaluate the efficacy of mineral remedies in bronchial asthma using the Lara Asthma Symptom Scale (LASS) as an assessment tool. Patients aged 15–45 years diagnosed with bronchial asthma will be included, while those with other major respiratory or systemic diseases will be excluded. Assessment will be based on LASS scores before and after treatment, with data analyzed using the paired t-test.
The study is expected to provide evidence on the role of mineral remedies in improving symptom severity and quality of life in bronchial asthma patients. |