| CTRI Number |
CTRI/2024/12/077701 [Registered on: 05/12/2024] Trial Registered Prospectively |
| Last Modified On: |
04/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of homoeopathic medicines in the treatment of bronchial asthma |
|
Scientific Title of Study
|
To Compare the effectiveness of individualized homoeopathic medicines versus Natrum Sulphuricum in the treatment of bronchial asthma : A randomized controlled clinical 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 |
Dr Nazreen |
| Designation |
PG Scholar |
| Affiliation |
Dr B R Sur Homoeopathic Medical College, Hospital and Research Centre |
| Address |
OPD and IPD, Dr B R Sur Homoeopathic Medical College, Hospital and Research Centre, Nanak Pura, Moti Bagh, New Delhi-110021
South West
DELHI
110021
India |
| Phone |
9582477287 |
| Fax |
|
| Email |
drnazreenkhan95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr U Rajeev Nair |
| Designation |
Professor & HOD, Department of Materia Medica |
| Affiliation |
Dr B R Sur Homoeopathic Medical College, Hospital and Research Centre |
| Address |
Department of Homoeopathic Materia Medica , 3rd Floor, Dr B R Sur Homoeopathic Medical College, Hospital and Research Centre, Nanak Pura, Moti Bagh, New Delhi-110021
South West
DELHI
110021
India |
| Phone |
9868393285 |
| Fax |
|
| Email |
drrajivh@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nazreen |
| Designation |
PG Scholar |
| Affiliation |
Dr B R Sur Homoeopathic Medical College, Hospital and Research Centre |
| Address |
Department of Homoeopathic Materia Medica, 3rd floor, Dr B R Sur Homoeopathic Medical College, Hospital and Research Centre, Nanak Pura, Moti Bagh, New Delhi- 110021
South West
DELHI
110021
India |
| Phone |
9582477287 |
| Fax |
|
| Email |
drnazreenkhan95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr B R Sur Homoeopathic Medical College, Hospital and Research Centre, Nanak Pura, Moti Bagh, New Delhi-110021, India |
|
|
Primary Sponsor
|
| Name |
Dr Nazreen |
| Address |
Dr B R Sur Homoeopathic Medical College, Hospital and Research Centre, Nanak Pura, Moti Bagh, New Delhi-110021, India |
| 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 Nazreen |
Dr B R Sur Homoeopathic Medical College, Hospital and Research Centre |
OPD AND IPD, Dr B R Sur Homoeopathic Medical College, Hospital and Research Centre, Nanak Pura, Moti Bagh
South West
DELHI |
9582477287
drnazreenkhan95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics committee Dr B R Sur Homoeopathic medical college and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J452||Mild intermittent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Individualized Homoeopathic Medicines |
Individualized Homoeopathic
Medicines will be administered
in centesimal potencies, selected according to homoeopathic principles. The dose and repetition will be done as per the requirement of each case. The route of administration will be Oral, in globules form. Duration: 6 months |
| Intervention |
Natrum Sulphuricum |
Natrum Sulphuricum will be administered in centesimal potencies, selected according to homoeopathic principles. The dose and repetition will be done as per the requirement of each case. The route of administration will be Oral, in globules form. Duration: 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Both sexes of age group above 18 years and below 60 years, irrespective of their race, caste, religion & socioeconomic status.
2. Persons have allergic asthma, occupational, exercise induced asthma and have intrinsic factors.
3. Mild to moderate cases will be taken.
4. Patient willing to give voluntary written informed consenF. |
|
| ExclusionCriteria |
| Details |
1. Bronchial asthma patients suffering from any life-threatening illness who are terminally ill, under immunosuppressive treatment or self-reported immune-compromised state.
2. Patients of malignancy or too sick for consultation.
3. Diagnosed case of mental illness / psychiatric/ other uncontrolled life threatening illness
affecting quality of life /any organ failure.
4. Pregnant ladies are excluded.
5. Substance abuse and or dependence.
6. Recent myocardial infarction on just or one month duration.
7. Unwilling to take part and not giving consent to join the study. Patients unable to comply
with the study protocol. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effectiveness of individualized homoeopathic medicines in comparison to Natrum Sulphuricum in the treatment of bronchial asthma |
1 year (12 months) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the effect of homoeopathic medicines on lung vital capacity in cases of Bronchial Asthma patients using spirometry.
2. To assess the improvement in quality of life by using Asthma quality of life questionnaire after giving homoeopathic medicines |
1 year (12 months) |
|
|
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 3 |
|
Date of First Enrollment (India)
|
16/12/2024 |
| 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
|
This study compares the effectiveness of individualized homeopathic medicines and Natrum Sulphuricum in treating patients with Bronchial Asthma, aged 18-60 years. Patients will be randomly assigned to receive either individualized homeopathic medicines or Natrum Sulphuricum. The study will measure the outcomes using Spirometry and AQLQ ( Asthma Quality of Life Questionnaire) scores. The primary goal is to compare the efficacy of these two approaches in managing bronchial asthma, improving quality of life, and reducing disease severity. The results will provide valuable insights into the effectiveness of homeopathic approaches in treating bronchial asthma. |