| CTRI Number |
CTRI/2023/02/049490 [Registered on: 06/02/2023] Trial Registered Prospectively |
| Last Modified On: |
02/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to see the effect of Viola Odorata(homoeopathic medicine) in treatment of Chronic Bronchitis |
|
Scientific Title of Study
|
A single blind clinical study to assess the efficacy of Viola Odorata in management of Chronic Bronchitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ruchita Jerath |
| Designation |
Doctor PG Scholar |
| Affiliation |
BVDU Homoeopathic Medical College, Department of Materia Medica |
| Address |
Bharati Vidyapeeth (Deemed to be University), Homoeopathic Medical College and Hospital,Dept. of Materia Medica,1st floor, OPD No.6, Pune Bangalore Highway,Pune,Maharashtra 411046
Bharati Vidyapeeth (Deemed to be University), Homoeopathic Medical College and Hospital,Dept of Materia Medica, OPD No.6, 1st floor, Pune Bangalore Highway, Pune,Maharashtra 411046
Pune
MAHARASHTRA
411043
India |
| Phone |
9419275634 |
| Fax |
|
| Email |
Jerathruchita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha V Jadhavrao |
| Designation |
Assistant Professor |
| Affiliation |
BVDU Homoeopathic Medical College, Department of Post Graduate and Research Centre |
| Address |
Bharati Vidyapeeth (Deemed to be University), Homoeopathic Medical College and Hospital,Dept. of Materia Medica,1st floor, OPD No.6, Pune Bangalore Highway,Pune,Maharashtra 411046
Bharati Vidyapeeth (Deemed to be University), Homoeopathic Medical College and Hospital,Dept of Materia Medica, OPD No.6, 1st floor, Pune Bangalore Highway, Pune,Maharashtra 411046
Pune
MAHARASHTRA
411043
India |
| Phone |
9923003441 |
| Fax |
|
| Email |
Neha.jadhavrao@Bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ruchita Jerath |
| Designation |
Doctor PG Scholar |
| Affiliation |
BVDU Homoeopathic Medical College, Department of Post Graduate and Research Centre |
| Address |
Bharati Vidyapeeth (Deemed to be University), Homoeopathic Medical College and Hospital,Dept. of Materia Medica,1st floor, OPD No.6, Pune Bangalore Highway, Pune, Maharashtra 411046
Bharati Vidyapeeth (Deemed to be University), Homoeopathic Medical College and Hospital,Dept of Materia Medica, OPD No.6, 1st floor, Pune Bangalore Highway, Pune,Maharashtra 411046
Pune
MAHARASHTRA
411043
India |
| Phone |
9419275634 |
| Fax |
|
| Email |
Jerathruchita@gmail.com |
|
|
Source of Monetary or Material Support
|
| BVDU Homoeopathic Medical College, Department of Post Graduate and Research Centre |
|
|
Primary Sponsor
|
| Name |
Dr Ruchita Jerath |
| Address |
BHARATI VIDYAPEETH (Deemed to be University),
HOMOEOPATHIC MEDICAL COLLEGE AND HOMOEOPATHIC
HOSPITAL, DEPT. OF POST-GRADUATE AND RESEARCH
CENTRE, Pune-Bangalore Highway, Pune |
| 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 Ruchita Jerath |
BVDUHMC, Pune |
Bharati Vidyapeeth (Deemed to be University), Homoeopathic Medical College and Hospital, Dept. Of Materia Medica OPD. NO. 6, Floor No. 1, Pune Bangalore Highway,
Pune,
Maharashtra
411046
Pune
MAHARASHTRA |
9419275634
Jerathruchita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Bharati Vidyapeeth (DTU) HMC Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J42||Unspecified chronic bronchitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Viola Odorata |
Potentised homoeopathic medicine Viola Odorata in the form of pills or powder.
Dose: Viola Odorata based on the symptom similarity will be prescribed in appropriate
potency and doses based on the susceptibility of each individual case.
Route of Administration: oral.
Duration of therapy 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Those cases fulfilling the CBSS criteria and suffering is since 2 years or more.
2. Patients of All sexes will be included in the study.
3. Patients of 18 to 40 years age groups of various socio-economic groups will be included.
4. Patient without any other systemic diseases.
5. Patient giving written consent form.
6. Patients coming under the case definition according to CBSS will be included. |
|
| ExclusionCriteria |
| Details |
1. That doesn’t fulfill CBSS criteria.
2. Cases with serious complication of Respiratory system and/or recently taking strong steroidal medication and having acute exacerbation of bronchitis.
3. Patients with Psychiatric diagnosis.
4. Pregnant and lactating women.
5. Malignancy cases.
6. Recent major surgery.
7. Immuno compromised cases.
8. Patients who have participated in any other Research study in last 6 months
9.Those under other medications for other diseases. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To check the effectiveness of Viola Odorata in cases of Chronic Bronchiti using chronic bronchitis severity scale at day 1 and at every follow up. |
Improvement according to chronic bronchitis severity scale at day 1 and again after
every 15 days, for the total of 12 weeks will be assessed in every case to see the effect of viola odorata. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To give the maximum relief of symptoms of the patient by following up at every 7 days and to minimize the frequency of symptom of cough and wheezing in patient using CAT assessment. |
CAT assessment used at day 1 and at every 7 days so assess the frequency of symptoms of cough and wheezing patients within 12 weeks of duration. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
06/02/2023 |
| Date of Study Completion (India) |
07/12/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is the Non-Randomized, Single Blind Clinical trial to assess the effect of homoeopathic medicine Viola Odorata in the management of chronic Bronchitis in patients . The duration of treatment will be 3 months and will be done on 30 patients at Bharati Vidyapeeth (Deemed to be University) Homoeopathic Medical College and Hospital, Pune. The severity of the disease will be measured by Chronic Bronchitis severity scale on Day 1. The primary outcome will measure the effectiveness of Viola Odorata, that will be assessed from the follow-ups taken for 3 months. The secondary outcome will be measured by studying the reduction in the symptoms of chronic Bronchitis. |