| CTRI Number |
CTRI/2021/06/034157 [Registered on: 10/06/2021] Trial Registered Prospectively |
| Last Modified On: |
05/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of assessment of susceptibility with focus on respiratory tract infection in age group of 18 years to 40 years. |
|
Scientific Title of Study
|
Assessment of susceptibility with focus on respiratory tract infection in age group of 18 years to 40 years. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Moirangthem Krishnakumari Devi |
| Designation |
PG Scholar |
| Affiliation |
Bharati Vidyapeeth Deemed to be University Homoeopathic Medical College, Pune |
| Address |
Bharati Vidyapeeth Educational Campus, Pune- Satara Road, Pune- 411043
MAHARASHTRA
Bharati Vidyapeeth Educational Campus, Pune- Satara Road, Pune- 411043
MAHARASHTRA
Pune
MAHARASHTRA
411043
India |
| Phone |
8073914709 |
| Fax |
|
| Email |
kkmoirangthem18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinodini Vasantrao Patil |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth Deemed to be University Homoeopathic Medical College, Pune |
| Address |
Bharati Vidyapeeth Educational Campus, Pune- Satara Road,
Pune- 411043
Bharati Vidyapeeth Educational Campus, Pune- Satara Road,
Pune- 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
9890127840 |
| Fax |
|
| Email |
dr.vinodinipatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Moirangthem Krishnakumari Devi |
| Designation |
PG Scholar |
| Affiliation |
Bharati Vidyapeeth Deemed to be University Homoeopathic Medical College, Pune |
| Address |
Bharati Vidyapeeth Educational Campus, Pune- Satara Road,
Pune- 411043
Bharati Vidyapeeth Educational Campus, Pune- Satara Road,
Pune- 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
8073914709 |
| Fax |
|
| Email |
kkmoirangthem18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth Homoepathic Medical Hospital , Pune-satara road |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [No sponser] |
|
|
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 Moiranhthem Krishnakumari Devi |
Bharati Vidyapeeth Homoeopathic Medical College and Hospital Pune |
Bharati Vidyapeeth Educational Campus, Bharati Vidyapeeth Homoeoapthic Hospital, Department
of Homoeopathic Philosophy and Organon of Medicine, 3rd Floor. Pune- Satara Road, Pune- 411043 Pune
MAHARASHTRA
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
8073914709
kkmoirangthem18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Bharati Vidyapeeth Deemed to be University Homoeopathic Medical College, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J069||Acute upper respiratory infection,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic similimum |
Potentized homoeopathic medicine in the form of pills powder and dilution. Dose: The final selected remedy based on the individual totality will be prescribed in appropriate potency and doses based on the susceptibility of each individual case. Route of administration: Oral. Duration of therapy: 2 months. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Various socioeconomic groups will be included.
2. Patients of 18 - 40 years of age groups who fulfilled the standard case definition.
3. Patients of both sexes will be included in the study.
4. Patient without any other systemic diseases.
5. Patient giving written consent form. |
|
| ExclusionCriteria |
| Details |
1. That doesn‘t fulfil the diagnostic criteria.
2. Patients of regular medical care for any other chronic conditions like congenital malformation of respiratory tract, specific lungs disease.
3. Patients undertaking immune suppressive therapy will be excluded.
4. Patients with Psychiatric diagnosis.
5. Recent major surgery.
6. Patients requiring emergency medical care.
7. Patients who have participated in any other Research study in the last 6 months.
8. Those under other medications. Or using any other medicine during the study period.
9. Pregnant and lactating women.
10. Patient who are not written the consent form.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Improvement in the Wisconsin-Upper-Respiratory-Symptom-Survey-21
before and after the treatment.
2. To investigate the utility and efficacy of homoeopathic medicine for the
treatment of acute and recurrent URTIs. |
1. Improvement in the Wisconsin-Upper-Respiratory-Symptom-Survey-21 at day 1 and again
after every 15 days, for the total of 3 months.
2. Quality of life questionnaire assessment will be done in every follow-up for 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the changes in quality of life of patient with acute and recurrent URTIs after taking treatment. |
Assessment on day 1 and after 3 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 3 |
|
Date of First Enrollment (India)
|
20/06/2021 |
| 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
|
There is a general misconception that homoeopathy as a medical science is more efficacious in chronic diseases than in acute diseases. Contrary to this misconception homoeopathy also has a better scope in acute diseases, as the susceptibility is very prominent, sensitivity is high and the reactivity is quick. Hence, to medicine in acute disease is becoming more susceptibility. Homoeopathy being an effective system of medicine deals with any disease condition in a holistic way and caters to the needs of the present scenario and possesses a better scope for the treatment of Respiratory tract infection. A proper understanding of the dynamic concept of disease of susceptibility and of remedy is essential grasp of the most important aspect of homoeopathic practice. The ever changing kaleidoscopic picture presented by homoeopathic posology consists of well with the firm application of the law of similar and the concept of susceptibility. |