| CTRI Number |
CTRI/2015/02/005515 [Registered on: 09/02/2015] Trial Registered Retrospectively |
| Last Modified On: |
09/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the efficacy of Leucronil tablets in the patients suffering from white discharge per vagina |
|
Scientific Title of Study
|
Effect of Leucronil® tablets in the patients with Leucorrhea: An open clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Supriya Bhalerao |
| Designation |
Scientist |
| Affiliation |
Interactive Research School for Health Affairs |
| Address |
Interactive Research School for Health Affairs
Bharati Vidyapeeth Deemed University
Dhankawadi
Pune-Satara Road Pune
Interactive Research School for Health Affairs
Bharati Vidyapeeth Deemed University
Dhankawadi
Pune-Satara Road Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9869555272 |
| Fax |
|
| Email |
supriya.bhalerao@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Supriya Bhalerao |
| Designation |
Scientist |
| Affiliation |
Interactive Research School for Health Affairs |
| Address |
Interactive Research School for Health Affairs
Bharati Vidyapeeth Deemed University
Dhankawadi
Pune-Satara Road Pune
Interactive Research School for Health Affairs
Bharati Vidyapeeth Deemed University
Dhankawadi
Pune-Satara Road Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9869555272 |
| Fax |
|
| Email |
supriya.bhalerao@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Supriya Bhalerao |
| Designation |
Scientist |
| Affiliation |
Interactive Research School for Health Affairs |
| Address |
Interactive Research School for Health Affairs
Bharati Vidyapeeth Deemed University
Dhankawadi
Pune-Satara Road Pune
Interactive Research School for Health Affairs
Bharati Vidyapeeth Deemed University
Dhankawadi
Pune-Satara Road Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9869555272 |
| Fax |
|
| Email |
supriya.bhalerao@gmail.com |
|
|
Source of Monetary or Material Support
|
| SHREE BAIDYANATH AYURVED BHAVAN |
|
|
Primary Sponsor
|
| Name |
yurvedic Research Foundation Pvt ltd |
| Address |
Adm office Shree Baidyanath Ayurved Bhavan
20 Great Nag road
Nagpur 440009 |
| 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 |
| Dr Supriya Bhalerao |
BVDU College of Ayurved |
BVDU college of Ayurved
Deptment of Prasootitantra and stree roga Room no 13 Dhankawadi
Pune-Satara Road
Pune 411043
Pune
MAHARASHTRA |
9869555272
supriya.bhalerao@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BVDU College of ayurved |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N80-N98||Noninflammatory disorders of female genital tract, patients suffering from Leucorrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Tab Lucronil
|
Ashwagandha Extract (Withania somnifera 40 mg
Vidari Extract (Pueraria tuberosa)20 mg
Badi Elaichi Extract (Amomum subulatum)30 mg
Ashok Chhal Extract (Saraca
indica) 40 mg
Lodhra Chhal Extract (Symplocos racemosa) 60 mg Haldi Extract(Curcuma longa) 40 mg
Chirayta Extract (Swertia chirata) 30 mg
Adusa Extract (Adhotoda vasica) 30 mg
Belgiri Extract (Aegle marmalos) 30 mg
Guduchi Extract (Tinospora cordifolia) 30 mg
Majufal Extract (Quercus infectoria) 20 mg
Shatavari (Asparagus Racemosus) 30 mg
Dugdhapashan (Silicate of Manganese) 30 mg
2 tablets twice a day with water after food orally
for 30 days
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Married females of Age group 20 to 40 years having leucorrhoea due to non-infective cervical lesions e.g. cervical erosion, chronic cervicitis, mucous polyps, increased pelvic congestion e.g. uterine prolapsed, acquired retroverted uterus, chronic pelvic inflammation
Controlled diabetes
|
|
| ExclusionCriteria |
| Details |
i. Pregnant or lactating women
ii. Patients on Oral Contraceptive Pills
iii. Patients with IUCD
iv. Patients with physiological leucorrhoea (e.g. during ovulation, pre-menstrual, pregnancy)
v. Patients with abnormal (excessive) vaginal discharge due to neoplasmic changes
vi. Positive history of venereal diseases
vii. Patients suffering from uncontrolled diabetes
viii. Patients with Anemia (Hb% below 7)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The outcomes of the study will be measured in terms of clinical signs - per vaginal examination and symptoms
Pap smear test
microbiological improvement.
|
Every 15 days for a period of one month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety and tolerability of the formulation in patientsa suffering from Leucorrhea |
Every 15 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/07/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The primary purpose of the study is to evaluate the clinical efficacy of Tab.Lucronil - a polyherbal formulation on the signs and symptoms of leucorrhea and also the tolerabilliy of the formulation clinically on patients suffering from Leucorrhea.
|