| CTRI Number |
CTRI/2019/04/018852 [Registered on: 30/04/2019] Trial Registered Prospectively |
| Last Modified On: |
29/04/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Other (Specify) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Safety & Efficacy assessment of new Ayurvedic antimicrobial vaginal tablet for the treatment of leucorrhea through clinical trials. |
|
Scientific Title of Study
|
Estimation of the therapeutic efficacy of a novel Ayurvedic Vaginal tablet in treating excessive abnormal vaginal discharge during Phase II clinical trials |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mradu Gupta |
| Designation |
Professor and HOD |
| Affiliation |
Institute of Post Graduate Ayurvedic Education and Research |
| Address |
Room No. 2, Department of Dravyaguna, Institute of Post Graduate
Ayurvedic Education and Research 294/3/1 A. P. C. Road
Kolkata
WEST BENGAL
700009
India
Kolkata WEST BENGAL 700009 India |
| Phone |
9433665125 |
| Fax |
|
| Email |
mradu_gupta@hotmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mradu Gupta |
| Designation |
Professor and HOD |
| Affiliation |
Institute of Post Graduate Ayurvedic Education and Research |
| Address |
Room No. 2, Department of Dravyaguna, Institute of Post Graduate
Ayurvedic Education and Research 294/3/1 A. P. C. Road
Kolkata
WEST BENGAL
700009
India
WEST BENGAL 700009 India |
| Phone |
9433665125 |
| Fax |
|
| Email |
mradu_gupta@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Mradu Gupta |
| Designation |
Professor and HOD |
| Affiliation |
Institute of Post Graduate Ayurvedic Education and Research |
| Address |
Room No. 2, Department of Dravyaguna, Institute of Post Graduate
Ayurvedic Education and Research 294/3/1 A. P. C. Road
Kolkata
WEST BENGAL
700009
India
WEST BENGAL 700009 India |
| Phone |
9433665125 |
| Fax |
|
| Email |
mradu_gupta@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Post Graduate Ayurvedic Education and Research Kolkata (from ICMR sanctioned project fund vide No. 5/10/FR/7/2018 - RCH dated 11.6.2018) |
|
|
Primary Sponsor
|
| Name |
Institute of Post Graduate Ayurvedic Education and Research |
| Address |
294/3/1 A. P. C. Road Kolkata -700009 |
| 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 Mradu Gupta |
Institute of Post Graduate Ayurvedic Education and Research |
Room No. 2,
Department of
Dravyaguna, IPGAE&R, 294/3/1
A. P. C. Road Kolkata
-700009
Kolkata WEST BENGAL |
9433665125
mradu_gupta@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee for Clinical Trial on Human subjects at Institute of Post Graduate Ayurvedic Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N761||Subacute and chronic vaginitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ayurvedic mucoadhesive
vaginal tablet combination of equal amounts of
dried parts of the stem bark of Udumber Ficus glomerata Roxb.andLodhra
Symplocos racemosa Roxb |
One Ayurvedic novel formulated and standardized vaginal tablet per day up to 15 days at night & proper cleaning of the external genital parts of female patients |
| Comparator Agent |
Standard candid vaginal tablet |
Per vaginal standard tablet up
to 15 days |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1 Continuous per vaginal excessive abnormal white discharge
except ovulation period
2 Itching around the external genital parts
3 Pain in the back region
4 Painful intercourse |
|
| ExclusionCriteria |
| Details |
1 Pregnancy
2 History of significant per vaginal bleeding
3 prolapsed of uterus
4 Malignancy in the internal genital parts
5 Allergy to known constituents
6 Severely ill patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in excessive abnormal vaginal
discharge and associated symptoms,
improvement in genital health condition and well
beings. |
The final outcome of each participant will be evaluated after 15 days of treatment,i.e at the end of her study period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The primary outcome will be justified on the
basis of vaginal fluid study, microbiological
study, Routine haematological investigation,hormone FSH, LH, TSH analysis and also urine in this study |
Day 1 Day 15 Pre treatment and post treatment analysis |
|
|
Target Sample Size
|
Total Sample Size="210" Sample Size from India="210"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
15/05/2019 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
1.Mradu Gupta et al, Pharmacognostic and Chemical Standardization of Vaginal Herbal Formulation Extracts Using Spectroscopy (UV-VIS & FTIR) and Chromatography (HPTLC, HPLC & GC-MS) Methods, International journal of Pharmacy and Pharmaceutical Research, Human journals, 2017; 9(2): 21-51.
2.Mradu Gupta et al, Formulation, development and standardization of an Ayurvedic muco-adhesive extended release vaginal tablet, International Journal of Pharmacognosy, 2018; 5(1):15-25.
3.Mradu Gupta et al, Design and Standardization of Novel Muco-Adhesive Vaginal Herbal Tablet for Treatment of Leucorrhea Using In-Vitro & In-Situ Methods, International Journal of Pharmaceutical Sciences Review and Research, 2017; 45(2): 187-197.
4.Mradu Gupta et al, Assessment of oral toxicity and vaginal irritation test of novel antimicrobial mucoadhesive herbal vaginal tablet for the treatment of vaginitis, International Journal of Green Pharmacy,2018:12(1): 15-24.
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The per vaginal excessive abnormal discharge of vagina, itching around the external part of genital organs are common symptoms of large population of female patients in India due to unhygienic condition, poor diet, general weakness etc. Vaginal complaints are very common in the general population and are one of the most frequent reasons for patient visits to obstetrician-gynecologists. Vaginitis is defined as the spectrum of conditions that cause vulvo-vaginal symptoms. Chronic vaginal problems have a significant impact in the overall health and well-being of affected women. It is a disease which is mentioned by the Charak in the Charak Samhita under the upadravas of Yoni-Vyapat Roga (Ch. Chikitsa 30/39 & 131) in the pradar roga that means excessive abnormal discharge coming out from the vagina. There are two type of this disease based on the basis of colour of the discharge. If excessive abnormal vaginal discharge is yellowish-white, thick & purulent it is called Sweta Pradar (Leuchorrhea). Although leucorrhoea is one of the most common female ailments, there is no safe, cost-effective antimicrobial Ayurvedic herbal vaginal tablet having for its treatment. The aim of present study is to develop once daily muco-adhesive extended release vaginal delivery system for the herbal combination drug having stem bark of Ficus glomerata Roxb. and Symplocos racemosa Roxb plants which is designed to improve the adhesion to the vagina in order to prolong the residence time and consequently to obtain a long therapeutic concentration at the site of infection. Formulated Ayurvedic herbal vaginal tablets have been evaluated and standardized for bio-adhesive properties, in vitro and in situ release studies, in vitro swelling studies and stability studies along with phytochemical standardization for marker compound and in vitro anti-microbial property. After getting the significant result of the standardized Ayurvedic vaginal tablet, the clinical trial on female human subject will be done for the treatment of Sweta prader (Excessive vaginal discharge) called Lecucorrhea and other associated symptoms in the hospital of this Institute. The research effort will establish the pre-clinical efficacy and clinical study of a proposed herbal formulation after rigorous scientific evaluation through phytochemical studies, antimicrobial, antibacterial, antifungal and concerned animal experiments (Acute toxicity, Dermal toxicity and mucosal toxicity). This novel research vaginal tablet will be a cost effective, safe, easy to use, easily available antimicrobial herbal standardized drug for the treatment of leucorrhoea in female human subjects.
Publications: 1.Mradu Gupta et al, Pharmacognostic and Chemical Standardization of Vaginal Herbal Formulation Extracts Using Spectroscopy (UV-VIS & FTIR) and Chromatography (HPTLC, HPLC & GC-MS) Methods, International journal of Pharmacy and Pharmaceutical Research, Human journals, 2017; 9(2): 21-51. 2.Mradu Gupta et al, Formulation, development and standardization of an Ayurvedic muco-adhesive extended release vaginal tablet, International Journal of Pharmacognosy, 2018; 5(1):15-25. 3.Mradu Gupta et al, Design and Standardization of Novel Muco-Adhesive Vaginal Herbal Tablet for Treatment of Leucorrhea Using In-Vitro & In-Situ Methods, International Journal of Pharmaceutical Sciences Review and Research, 2017; 45(2): 187-197. 4.Mradu Gupta et al, Assessment of oral toxicity and vaginal irritation test of novel antimicrobial mucoadhesive herbal vaginal tablet for the treatment of vaginitis, International Journal of Green Pharmacy,2018:12(1): 15-24. |