| CTRI Number |
CTRI/2024/09/073547 [Registered on: 06/09/2024] Trial Registered Prospectively |
| Last Modified On: |
28/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Explorative study |
| Study Design |
Other |
|
Public Title of Study
|
Discharge from Vagina which is caused by dosha and also bacteria and fungi to identify them and corelate them |
|
Scientific Title of Study
|
Identification and categorization of pathogens in yonisrava vis a vis abnormal vaginal discharge- An explorative study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR. SUNAND MUTARE |
| Designation |
PG Scholar |
| Affiliation |
JSS Ayurveda Medical College |
| Address |
2nd Year PG scholar
Department of PG studies in Roganidana evam vikriti vigyana
JSS Ayurveda medical college and hospital
#41/E Lalithadripura Road
Mysuru
Mysore
KARNATAKA
570028
India |
| Phone |
8861102617 |
| Fax |
2548299 |
| Email |
mutaresunanda7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhusudan B G |
| Designation |
HOD |
| Affiliation |
JSS Ayurveda Medical College |
| Address |
HOD
Department of Roganidana evam vikriti vigyan
JSS Ayurveda medical college and hospital Mysuru
# 41/E Lalithadripura Road
Mysuru
Mysore
KARNATAKA
570028
India |
| Phone |
9986284748 |
| Fax |
2548299 |
| Email |
drmadhusudanbg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunand Mutare |
| Designation |
PG Scholar |
| Affiliation |
JSS Ayurveda Medical College |
| Address |
2nd year PG Scholar
Department of PG studies in Roganidana evam vikriti vigyan
JSS Ayurveda medical college and hospital
#41/E Lalithadripura road
Mysuru
Mysore
KARNATAKA
570028
India |
| Phone |
8861102617 |
| Fax |
2548299 |
| Email |
mutaresunanda7@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS Ayurveda Medical College
Lalithadripura road
Mysuru 570028
Karnataka
India |
|
|
Primary Sponsor
|
| Name |
Sunand Mutare |
| Address |
PG Scholar
JSS Ayurveda Medical College
Lalithadripura road
Mysuru 570028
Karnataka
India |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 Sunand Mutare |
JSS Ayurveda hospital Mysuru |
Prasooti tantra/OPD/ 9
Mysore
KARNATAKA |
8861102617
mutaresunanda7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS Ayurveda Medical College Institutional Ethical Clearance Committee- Human |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B998||Other infectious disease. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Subject willing to participate in the study
subject having abnormal vaginal discharge
married and sexually active female of reproductive age group within 22-45 years |
|
| ExclusionCriteria |
| Details |
women in their menstrual bleeding phase.
positive HIV, HbsAG cases
known case of Cervical erosion ,Cervical polyp, STDs, carcinoma of reproductive organs |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Identification of pathogens in different Yonisrava as mentioned in texts of Ayurveda |
day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Categorization of pathogens in Yonisrava among Vata, Pitta and Kaphaja Yonisrava |
18 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
09/09/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This explorative study intends to search for new horizons in the field of treating infections. Abnormal Vaginal Discharge is defined as discharge that is different from usual with respect to colour / odour / consistency. Abnormal discharge is often associated with Vulvar pruritis, Dyspareunia, Dysuria or Lower abdominal pain. It may be a sign of infection in the Vagina or cervix. Common organisms are – Candida albicans, Gardnerella vaginalis, Trichomonas vaginalis. Though there is explanation available on Yonisrava, microbiological understanding of the same is missing. Thus this study intends to identify and categorise the pathogens in Yonisrava, thus to bridge the gap of Microbiology and Ayurveda understanding. |