| CTRI Number |
CTRI/2023/02/049386 [Registered on: 01/02/2023] Trial Registered Prospectively |
| Last Modified On: |
30/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Homoeopathy in treating vaginal discharge in married women |
|
Scientific Title of Study
|
Evaluating the role of individualised homoeopathic remedy selected from the compiled repertory in case of pathological leucorrhoea : An open label prospective Quasi experimental study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dimple Kumari |
| Designation |
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 Repertory, Post graduate and Research Centre,floor no.3, Pune Bangalore highway,Pune-411046
Bharati Vidyapeeth (Deemed to be University),Homoeopathic Medical College and hospital, Dept of Repertory, Post graduate and Research Centre,floor no.3, Pune Bangalore highway,Pune-411046
Pune
MAHARASHTRA
411046
India |
| Phone |
7400150724 |
| Fax |
|
| Email |
dimple.mdogra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mrs Anita S Patil |
| Designation |
HOD Repertory, Dean Faculty of Homoeopathy |
| Affiliation |
BVDU Homoeopathic Medical College, Department of Post Graduate and Research Centre, Pune,Maharashtra |
| Address |
Bharati Vidyapeeth (Deemed to be University),Homoeopathic Medical College and hospital, Dept of Repertory, Post graduate and Research Centre,floor no.3, Pune Bangalore highway,Pune-411046
Bharati Vidyapeeth (Deemed to be University),Homoeopathic Medical College and hospital, Dept of Repertory,Post graduate and Research centre, floor no. 3, Pune Bangalore highway, Pune-411046
Pune
MAHARASHTRA
411046
India |
| Phone |
9657729907 |
| Fax |
|
| Email |
anitap405@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dimple Kumari |
| Designation |
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 Repertory, Post graduate and Research Centre,floor no.3, Pune Bangalore highway,Pune-411046
Bharati Vidyapeeth (Deemed to be University),Homoeopathic Medical College and hospital, Dept of Repertory, Post graduate and Research Centre,floor no.3, Pune Bangalore highway,Pune-411046
Pune
MAHARASHTRA
411046
India |
| Phone |
7400150724 |
| Fax |
|
| Email |
dimple.mdogra@gmail.com |
|
|
Source of Monetary or Material Support
|
| BVDU Homoeopathic Medical College, Department of Post Graduate and Research Centre |
|
|
Primary Sponsor
|
| Name |
Dr Dimple Kumari |
| Address |
BHARATI VIDYAPEETH (Deemed to be University),
HOMOEOPATHIC MEDICAL COLLEGE AND HOMOEOPATHIC
HOSPITAL, DEPT. OF POSTGRADUATE AND RESEARCH CENTRE, Pune Bangalore Highway |
| 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 Dimple Kumari |
BVDUHMC, Pune |
Bharati Vidyapeeth (Deemed to be University),Homoeopathic Medical College and hospital, Dept of Repertory, Post graduate and Research Centre,floor no.3,OPD No. 5, Pune Bangalore highway,
Pune
Maharashtra
411046
Pune
MAHARASHTRA |
7400150724
dimple.mdogra@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: R688||Other general symptoms and signs, (2) ICD-10 Condition: B998||Other infectious disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Similimum |
Potentised homoeopathic medicine in the form of pills or powder.
Dose: The final selected remedy based on the Repertorial totality will be prescribed in appropriate potency(30,200 or 1M as required by patient) and doses based on the susceptibility of each individual case.
Route of Administration: Oral.
Duration of therapy: 3 months. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1 Patient attending OPD who is suffering from Leucorrhoea which is defined will be included
for the study.
2 Married Women irrespective of their religious and socio-economic status.
3 Patient who are willing to take part in the study.
|
|
| ExclusionCriteria |
| Details |
1 Patient taking oral contraceptives pills.
2 Patient having defined life-threatening pathology in genital tract.
3 Patient with Malignancy cases.
4 Pregnant women and lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To enlist the most frequently prescribed medicine for pathological Leucorrhea with their indication.
2.To evaluate change in the quality of life in Leucorrhea patients by homoeopathic medicines.
3.To determine the utility of compiled repertory for individualized homoeopathic treatment of pathological Leucorrhea. |
the follow ups taken at every 15 days will be assessed for duration of 3 months using vaginal assessment form and ORIDL score at the beginning and end of treatment i.e. after 12 weeks and most prescribed homoeopathic medicine using complied repertory will be evaluated. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compile a Leucorrhea based repertory from all well-known established repertories.
To evaluate change in the quality of life in Leucorrhea patients by homoeopathic medicines. |
The medicine will be given after complete repertorisation by using compiled repertory(which will be formed by compiling all well known repertories for pathological leucorrhea). The 5 follow up will be taken every 15 days to assess the relief in females of pathological leucorrhea |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/02/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is the Non Randomized, single blind open label prospective Quasi experimental study to see the results of the complied repertory in the treatment of pathological leucorrhea using Vaginal assessment form and ORIDL score. The duration of treatment will be 3 months and will be done on 50 patients at Bharati Vidyapeeth Medical Foundation Homoeopathic Hospital, peripheral O.P.D,various rural and urban camp series,O.P.D,I.P.D. The primary outcome will be assessed using the follow up taken for 3 months to see the effectiveness of homoeopathic medicines in the treatment of Pathological Leucorrhea. To see whether compiled repertory is useful in clinical prescribing of final similimum. The secondary outcome will measure the improvement in symptoms of patients using vaginal assessment form and ORIDL score at day 1 and 3rd month. |