| CTRI Number |
CTRI/2025/02/080158 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The Role of homeopathy in the treatment of leucorrhea |
|
Scientific Title of Study
|
A clinical trial on the efficacy of aletris farinosa in the treatment of leucorrhoea a single arm 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 Indira Singh |
| Designation |
HOD Department of Homoeopathic Materia Medica |
| Affiliation |
RBTS Government Homoeopathic Medical College and Hospital |
| Address |
Room number 3 Department of Homoeopathic Materia Medica PG
Block RBTS Government Homoeopathic Medical College and Hospital Muzaffarpur Bihar
Muzaffarpur BIHAR India
Muzaffarpur
BIHAR
842002
India |
| Phone |
7739560242 |
| Fax |
|
| Email |
singh.katyayni@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anupama Kumari |
| Designation |
PG Scholar |
| Affiliation |
RBTS Government Homoeopathic Medical College and Hospital |
| Address |
OPD-1-6 and PG Building RBTS Government Homoeopathic
Medical College and Hospital Muzaffarpur Bihar India
Room number 3 Department of Homoeopathic Materia Medica PG
Block RBTS Government Homoeopathic Medical College and Hospital Muzaffarpur Bihar
Muzaffarpur
Muzaffarpur
BIHAR
842002
India |
| Phone |
9681809567 |
| Fax |
|
| Email |
anupamanih@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anupama Kumari |
| Designation |
PG Scholar |
| Affiliation |
RBTS Government Homoeopathic Medical College and Hospital |
| Address |
OPD-1-6 and PG Building RBTS Government Homoeopathic
Medical College and Hospital Muzaffarpur Bihar India
Room number 3 Department of Homoeopathic Materia Medica PG
Block RBTS Government Homoeopathic Medical College and Hospital Muzaffarpur Bihar
Muzaffarpur
Muzaffarpur
BIHAR
842002
India |
| Phone |
9681809567 |
| Fax |
|
| Email |
anupamanih@gmail.com |
|
|
Source of Monetary or Material Support
|
| RBTS Government Homoeopathic Medical College and Hospital Muzaffarpur Bihar India 842002 |
|
|
Primary Sponsor
|
| Name |
RBTS Government Medical College and Hospita |
| Address |
Ramdayalu Nagar, Muzaffarpur, Bihar, 842002 |
| Type of Sponsor |
Government 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 Indira Singh |
RBTS Government Medical College and Hospital, Muzaffarpur,Bihar, 842002 |
OPD 1 OPD 3 OPD 6 and Hospital Block RBTS Govt Homoeopathic Medical College And Hospital
Muzaffarpur
BIHAR |
7739560242
singh.katyayni@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RBTS Government Medical College and Hospital-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N768||Other specified inflammation of vagina and vulva, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aletris farinosa homoeopathic medicine prescribed after analysing the totality of symptom. |
mother tincture as patient susceptibility for regular follow-up 2 weeks adhering strictly to the principles and guidelines of homoeopathy for the treatment of leucorrhoea. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
i Patient willing to give consent to take part in the study.
ii Patients having age group of 15 – 45 yrs.
iv Patients of the female sex and all religions.
v Patients are self-diagnosed and on previous treatment for Leucorrhea. |
|
| ExclusionCriteria |
| Details |
i Patients unwilling to take part or not giving
consent to join the study.
ii Diagnosed cases of systemic diseases,
psychiatric illness or other uncontrolled or
life-threatening illness affecting the quality of
life or any organ failure.
iii Patient of Age less than 15 years & greater
than 60 years.
iv Cases with impaired renal function.
v Substance abuse and/ or dependence.
vi Self-reported immune-compromised state
vii Pregnant and lactating females. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected from the study that it will reduce the recurrency rate and sign and symptom of leucorrhoea after a prescribed homoeopathic medicine on the basis of individualisation and at acts curatively in case of leucorrhoea with no side effect. |
10 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To know the importance of remedies indicating symptoms of leucorrhoea.
To use a scoring system to asses the quality of life in leucorrhoea.
To compare the symptomatic changes of patients before and after homoeopathic treatment. |
1year |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
17/02/2025 |
| 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
|
Leucorrhea, or vaginal discharge, is a whitish or yellowish fluid from the vagina, commonly occurring during puberty, the start of menstruation, or pregnancy. While normal physiological leucorrhea is caused by estrogen stimulation, it can sometimes be irritating during puberty. The purpose of this research to assess the efficacy of homoeopathic medicine in treating leucorrhoea as well as to evaluate the effects on quality of life. |