| CTRI Number |
CTRI/2021/04/032728 [Registered on: 12/04/2021] Trial Registered Prospectively |
| Last Modified On: |
08/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to evaluate the effect and safety of B C CAPS in Abnormal vaginal discharge due to microbial infections |
|
Scientific Title of Study
|
An Open label Clinical study to evaluate the efficacy and safety of B C CAPS manufactured by NUTRA GRACE in Abnormal vaginal discharge due to microbial infections |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PHAR/2021/NG/03, Version 01 dated 13 Feb 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Urvashi P Bhatara |
| Designation |
Principal Investigator |
| Affiliation |
Consultant- Department of Obstetrics & Gynecology |
| Address |
Rajalakshmi Hospital
Department of OBG
Ground Floor
Lakshmipura Main Road
Vidyaranyapura Post
Bangalore
KARNATAKA
560097 India
Bangalore
KARNATAKA
560097
India |
| Phone |
|
| Fax |
|
| Email |
urvashibhatara@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Baburao Vikram |
| Designation |
Director |
| Affiliation |
Pharexcel Consulting |
| Address |
Pharexcel Consulting
2nd floor, Clinical operations
11, 10th Cross,
AYR lay out,
Shettyhalli
Jalahalli West,
Bangalore
Bangalore
KARNATAKA
560015
India |
| Phone |
|
| Fax |
|
| Email |
info@pharexcelconsulting.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Sunil Gupta |
| Designation |
Managing Director |
| Affiliation |
Nutra Grace |
| Address |
NUTRA GRACE;
B-11/7 & 11/8,
IDA Uppal;
Hyderabad- 500039,
Telangana, INDIA.
Hyderabad
TELANGANA
500039
India |
| Phone |
|
| Fax |
|
| Email |
sunil@nutragrace.com |
|
|
Source of Monetary or Material Support
|
| NUTRA GRACE;
B-11/7 & 11/8,
IDA Uppal;
Hyderabad- 500039,
Telangana, INDIA |
|
|
Primary Sponsor
|
| Name |
NUTRA GRACE |
| Address |
B-11/7 & 11/8,
IDA Uppal;
Hyderabad- 500039,
Telangana,
INDIA |
| 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 Urvashi P Bhatara |
Rajalakshmi Hospital and Research Center |
Dept. of Gynaecology, Room Number 02, Ground floor, 21/1, Lakshmipura Main Road
Vidyaranyapura Post
Bangalore
KARNATAKA
560097 India
Bangalore
KARNATAKA |
9448696741
urvashibhatara@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajalakshmi Hospital Institutional Ethics Committee |
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: SWETAPRADARA(ABNORMAL VAGINAL DISCHARGE), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
B C CAPS
NIMBA BEEJA TAILA VAGINAL CAPSULES |
Each liquid filled hard elating contains Proporietory Blend of Neem Seed Oils 500 mg. 2 capsules to be administered manually in vagina before going to Bed for 14 days. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Age 18- 45 yrs
2. Subjects with presence of signs and symptoms such as irritation, soreness, dysuria, vulvovaginal inflammation (edema, erythema) and abdominal pain.
3. Subjects with confirmed laboratory diagnosis of abnormal vaginal discharge.
4. Subjects willing to give written informed consent and come for a regular follow up |
|
| ExclusionCriteria |
| Details |
1. Allergy to neem products.
2. Pregnant subjects.
3. Patients who had taken oral or intravenous antifungal agents within 4weeks or used topical vaginal antifungal drugs within 1 week before enrollment.
4. Terminally ill patients or patients with severe cardiac, hepatic renal or cerebrovascular disease, malignancy, chronic uncon-trolled systemic disease e.g. hypertension, collagen disorders, etc or any other serious medical illness.
5. Patients who have participated in a new drug study in the past 3 months.
6. Any other condition that in the opinion of the investigator does not justify the patient’s participation in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in microbiological parameters |
Baseline and Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Clinician’s assessment of symptoms |
Baseline, Day 7 and Day 14 |
| Change in Subjective assessment of symptoms |
Baseline and Day 1 to 14 |
| Continuous monitoring for AEs and SAEs |
Day 1 to 14 |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="15" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2021 |
| Date of Study Completion (India) |
14/05/2021 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
There are various synthetic antifungal medications and vaginal suppositories which are approved worldwide for the treatment of vaginal infections. The present composition of herbal drug B C CAPS is a formulation of neem seed oil having anti fungal, anti bacterial activity and anti viral which offers potential for therapeutic and prophylactic use at global level, especially in epidemics. Each of these properties offers specific healing components including inhibiting viruses and fungi, destroying bacteria, relieving pain, reducing inflammation and tenderness and eradicating other microorganisms. B C CAPS is a blended formulation of Neem seed oil which is very well known for their properties as an antimicrobial agent. Indicated for Genital Candidiasis, Chronic candida infection and bacterial vaginosis. There are no contra-indications or health risks associated with B C Capsules. 2 capsules to be administered manually in vagina before going to bed. |