| CTRI Number |
CTRI/2021/07/034778 [Registered on: 12/07/2021] Trial Registered Prospectively |
| Last Modified On: |
19/02/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study on White Free Capsule in White discharge |
|
Scientific Title of Study
|
A Clinical Evaluation of Efficacy and Safety of White-free Capsule in patients suffering from leucorrhoea- An open labeled, single center, non-comparative, interventional, prospective, clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| WHTFREE/LEUCO/JAGT/01-2021 Version 1.0, 16th June 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rahul R Kamde |
| Designation |
Assistant Professor & HOD |
| Affiliation |
KVTR Ayurvedic College and Hospital Boradi |
| Address |
Department of Prasuti Tantra and Streeroga, Ground Floor OPD no.1, KVTR Ayurved College, Boradi, Tal. Shirpur, Dist. Dhule
Dhule
MAHARASHTRA
425428
India |
| Phone |
9422815205 |
| Fax |
|
| Email |
kamderahul77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research |
| Address |
Target Institute of Medical Education and Research
A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research |
| Address |
Target Institute of Medical Education and Research
A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Jagat Pharma Pvt. Ltd
No- 23 B, Stadium Rd,
Model Town, Bareilly,
Uttar Pradesh 243122
|
|
|
Primary Sponsor
|
| Name |
Jagat Pharma Pvt Ltd |
| Address |
No- 23 B, Stadium Rd,
Model Town, Bareilly,
Uttar Pradesh 243122
|
| 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 Rahul R Kamde |
KVTR Ayurvedic College and Hospital, Boradi |
Department of Prasuti Tantra and Streeroga, Ground Floor OPD no.1, KVTR Ayurved College, Boradi, Tal. Shirpur, Dist. Dhule, 425428
Dhule
MAHARASHTRA |
9422815205
kamderahul77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, KVTR Ayurvedic College, Boradi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N898||Other specified noninflammatory disorders of vagina. Ayurveda Condition: Shvetapradar, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
White Free Capsule |
It contains Saraca indica , Asparagus racemosus, Cucurbita pepo, Tinospora cordifolia, Mucuna pruriens, Daemia extnsa, Commiphora mukul, Myristica fragrans, Woodfordia fruticosa and Moringa oleifera
Dosage and Treatment Duration: 2 capsules of White-Free two times daily orally after meals with water for 30 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1. Women must agree to practice reliable contraception [Intrauterine device (IUD), Tubal sterilization, Vasectomy in male partner. Participants who use a hormonal contraceptive as one of their birth control methods should have the same method for a minimum of 3 months before the first dose of study drug. Acceptable hormonal methods (every hormonal method must be used with a barrier method like a condom, preferably a male condom). Oral contraceptives, Injectable progesterone, Contraceptive vaginal ring. Acceptable barrier methods (should be used with a hormonal method) Male or female condom with or without spermicide] for 30 days following treatment
2. Presenting complaints of moderate grade Vaginal white discharge (moderate discharge, 3-4 days in a week, requires change of undergarments once daily), from last 15 days
3. Not currently menstruating or expected to in the next 4 days
4. Provide written informed consent before initiation of any study procedures and be available for all study visits
|
|
| ExclusionCriteria |
| Details |
1. Suffering from bacterial vaginosis (Purulent discharge with fishy smell) as per Investigator’s opinion
2. Women who had used prescribed medications (oral or topical antibiotics including metronidazole, clindamycin, tinidazole etc. Anti-fungal drugs including clotrimazole and ketoconazole etc.) for vaginal complaints in the past 2 weeks.
3. Including, but not limited to, ongoing or active infection, active liver, kidney or autoimmune diseases, uncontrolled diabetes, hypertension, cardiac diseases.
4. Subjects with known history of hepatitis B and/ or C
5. Patients on Oral Contraceptive Pills for last one month
6. Patients with IUCD for last one month
7. Known case of venereal disease
8. History of significant per vaginal bleeding over the last 1 month
9. Prolapsed of uterus
10. Known case of malignancy in the internal genital parts and known case of any malignancy
11. Allergy to any constituent of white free capsule
12. Any other condition due to which patients are deemed to be unsuitable by the investigator for reason(s) not specifically started in the exclusion criteria
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in symptoms associated with Leucorrhoea, Vaginal discharge and nature of discharge |
Day 0, Day 10, Day 20, Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Proportion of cases with complete cessation of symptoms of leucorrhoea over a period of 30 days
2. Requirement of rescue medications (use of antibiotics and other medications)
3. Global assessment for overall change by subject and investigator
4. Change in vitals and adverse events
5. Assessment of tolerability of study drug by assessing ADRs
|
Day 0, Day 10, Day 20, Day 30 |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
12/07/2021 |
| Date of Study Completion (India) |
16/11/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Yet Done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
It
was an open labeled, single center, non-comparative, interventional,
prospective, clinical study to evaluate efficacy and safety of White-free Capsule
in patients suffering from leucorrhoea. The study was conducted at single
site in India. Subjects were advised to take 2 capsules of White-Free two times
daily after meals with water for 30 days. The primary objective of the study
was to assess changes in symptoms associated with Leucorrhoea, Vaginal
discharge and nature of discharge. The secondary objectives of the study were
to assess proportion of cases with complete cessation of symptoms of leucorrhoea
over a period of 30 days, requirement of rescue medications (use of antibiotics
and other medications, global assessment for overall change by subject and
investigator at the end of study treatment, vitals and adverse events, tolerability
of study drug by assessing ADRs on Day 0, Day 10, Day 20 and Day 30.
Results and Conclusion:
Thirty days of treatment with White-free capsule was significantly effective in relieving leucorrhoea and associated symptoms. White-free capsule effectively reduced vaginal discharge within one week. White- free capsule was well tolerated by all the subjects as there were no adverse reactions reported. Thus, White-free capsule is safe and effective for the treatment of Leucorrhoea. |