| CTRI Number |
CTRI/2022/05/042522 [Registered on: 12/05/2022] Trial Registered Prospectively |
| Last Modified On: |
06/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Study on Bronchial asthma. |
|
Scientific Title of Study
|
The Efficacy of Homoeopathic Simillimum in treating Atopic Bronchial Asthma With an Evaluation based on Serum IgE. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Y Araafath |
| Designation |
PG Scholar |
| Affiliation |
Vinayaka Mission Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine Opd Room no 2e1 Vinayaka Mission Homoeopathic Medical College and Hospital NH47 Sankari Main road Seeragapadi Salem
Tamilnadu
636308
India
Salem
TAMIL NADU
636308
India |
| Phone |
8610229276 |
| Fax |
|
| Email |
dr.araafath97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr E Nisha Paul |
| Designation |
Professor and Head of Department |
| Affiliation |
Vinayaka Mission Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine Opd Room no 2e1 Vinayaka Mission Homoeopathic Medical College and Hospital NH47 Sankari Main road Seeragapadi Salem
Tamilnadu
636308
India
Salem
TAMIL NADU
636308
India |
| Phone |
9995680275 |
| Fax |
|
| Email |
Nisha.gopal2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr E Nisha Paul |
| Designation |
Professor and Head of Department |
| Affiliation |
Vinayaka Mission Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine Opd Room no 2e1 Vinayaka Mission Homoeopathic Medical College and Hospital NH47 Sankari Main road Seeragapadi Salem
Tamilnadu
636308
India
Salem
TAMIL NADU
636308
India |
| Phone |
9995680275 |
| Fax |
|
| Email |
Nisha.gopal2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Mission Homoeopathic Medical College and Hospital NH47 Sankari Main road Seeragapadi Salem Tamilnadu |
|
|
Primary Sponsor
|
| Name |
Vinayaka Mission Homeopathic Medical College and Hospital |
| Address |
NH47 Sankari Main road Seeragapadi Salem Tamilnadu 636308
India |
| 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 E Nisha Paul |
Vinayaka Mission Homoeopathic Medical College and Hospital |
Department of Organon of Medicine Opd Room no 2e1 Vinayaka Mission Homoeopathic Medical College and Hospital NH47 Sankari Main road Seeragapadi Salem Tamilnadu 636308
Salem
TAMIL NADU |
9995680275
Nisha.gopal2012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee Vinayaka Mission Kirupananda Variyar Medical College and Hospital Salem |
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 |
| Intervention |
Homoeopathic Medicine |
Homoeopathic Medicines are selected on basis of Symptom similarity The Dose is selected based upon individualization and susceptibility of the patient The Medicine is administered via orally and followup is taken in every 15 days and Maximum period of study is 6 months |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient selected from age 5 to 60 and patients with clinical presentation of Bronchial asthma and Patients with strong family history and previous atopic History |
|
| ExclusionCriteria |
| Details |
Patients suffering from other respiratory diseases
Patients suffering from other systemic diseases
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Serum IgE |
after 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It is expected that the proposed study will be useful in reducing the symptoms of Bronchial asthma and to improve the quality of life of the patients. |
After 6 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
|
Phase 4 |
|
Date of First Enrollment (India)
|
16/05/2022 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
|
Bronchial asthma is
characterized by chronic airway inflammation and increased airway
responsiveness leading to symptoms of wheeze, cough and dyspnea. The
prevalence of asthma is increasing steadily. Asthma ranks amongst the most common chronic
ailments of the globe. It is estimated that 300 million people worldwide
suffer from asthma. Annually 250,000 deaths are attributed to asthma, and its
complications. In our country, the disease is under recognized
and underrated. The WHO estimates that asthma contributes to the loss of 15
million disability-adjusted life years.
The
prevalence of asthma has increased markedly over the past 30 years. In
developed countries, approximately 10% of adults and 15% of children have
asthma. The majority of asthmatics have childhood onset of disease. Asthma often starts early in life. The prevalence
of asthma is increasing in all age group, despite major advances in
understanding the etiology and pathophysiology of asthma and development of
new therapeutic modalities to control symptoms and prevent exacerbations,
effective therapies are not widely used.
|
Homoeopathy has
a vital role in the treatment of asthma. . Hence, I selected the topic “THE EFFICACY OF HOMEOPATHIC SIMILLIMUM ON TREATING ATOPIC
BRONCHIAL ASTHMA WITH AN EVALUATION BASED ON SERUM IgEâ€
|