| CTRI Number |
CTRI/2023/02/049887 [Registered on: 20/02/2023] Trial Registered Prospectively |
| Last Modified On: |
03/02/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study to evaluate efficacy of Leuc syrup in leucorrohoea |
|
Scientific Title of Study
|
Single Armed Clinical Study to Evaluate Efficacy Of Leuc Syrup in Leucorrohoea |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nilofar Shaikh |
| Designation |
Associate Professor |
| Affiliation |
JS Ayurveda Mahavidhyalaya |
| Address |
Prasutitantra evam streeroga department
Js Ayurveda Mahavidhyalaya
Nadiad
College road
Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
9638508994 |
| Fax |
|
| Email |
Shaikhnilofar12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nilofar Shaikh |
| Designation |
Associate Professor |
| Affiliation |
JS Ayurveda Mahavidhyalaya |
| Address |
Prasutitantra evam streeroga department
Js Ayurveda Mahavidhyalaya
Nadiad
College road
Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
9638508994 |
| Fax |
|
| Email |
Shaikhnilofar12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nilofar Shaikh |
| Designation |
Associate Professor |
| Affiliation |
JS Ayurveda Mahavidhyalaya |
| Address |
Prasutitantra evam streeroga department
Js Ayurveda Mahavidhyalaya
Nadiad
College road
Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
9638508994 |
| Fax |
|
| Email |
Shaikhnilofar12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Petlad Mahal Arogya Mandal ,Pharmacy |
|
|
Primary Sponsor
|
| Name |
Petlad Mahal Arogya Mandal Pharmacy |
| Address |
Petlad Mahal Arogya Mandal Pharmacy Punarvasu,Nr.Railway crossing,Petlad Road,Nadiad, 387001 Dist.Kheda,Gujarat,Indiad |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
| DrNilofar Shaikh |
PD Patel Ayurved Hospital attached with Js Ayurved Mahavidhyalaya |
Room no.132
Prasutitantra Evam Streeroga Department
Kheda
GUJARAT |
9638508994
Shaikhnilofar12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition:N771||Vaginitis, vulvitis and vulvovaginitis in diseases classified elsewhere. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: LEUC SYRUP, Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 10(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1.Married women having age between 18 to 55 years.
2.Patients having any complaint of discharge per vagina, Itching sensation at vulva, Burning sensation in vagina, Pain in vagina, Foul smell from vagina , backache and pelvic pain.
|
|
| ExclusionCriteria |
| Details |
1.Female patients having pregnancy, breast feeding or post-delivery period.
2.Patients with any reproductive tract malignancy.
3.Patients with other systemic illness.
4.Patients with positive history of venereal diseases
5.Patients who are using CU-T or chemical method of contraception.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relieve in white discharge per vagina |
at base line , 14 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| White discharge per vagina |
base line,14 days,4 weeks |
|
|
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/03/2023 |
| 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="0"
Months="0"
Days="14" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Leucorrhoea or white discharge is a complaint
with which each woman suffers at least once in a lifetime. It refers to the
white or yellowish discharge from the vaginal canal. The symptoms of swetapradara either physiological or
pathological results into great discomfort and deep agony in the individuals1
Leucorrhoea is found significantly more in married females as compared to
unmarried, pregnant as compared to non-pregnant, and women of lower
socioeconomic status with high parity.2Symptoms of Leucorrhoea are somewhat similar to Shwetapradara
mentioned in Ayurvedic literature but there is no separate chapter given
in Brihatrayee. Commentator Chakrapani has explained the word Pandura-Asrigdara
as Shwetapradara in his commentary.3Taking into account the
side effects and adverse effects of contemporary management , The Ayurvedic management
can be recommended as a safer, feasible and effective therapy for the
management of leucorrhoea. In this study, Ayurveda management by LEUC
Syrup (combination of Extract of Ashwagandha, Lodhra, Udumber, Guduchi,
Vruddhadaru ; Nagakesara ) will be carried out to evaluate the efficacy in
leucorrhoea. |