CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2023/11/059587 [Registered on: 06/11/2023] Trial Registered Prospectively

Last Modified On:

27/10/2023

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Effect Of Arkadi Varti In Abnormal Vaginal Discharge

Scientific Title of Study

A Clinical Study To Evaluate The Role Of Arkadi Varti In Abnormal Vaginal Discharge Of Different Etiologies

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 KIRTI SISODIYA
Designation	MD SCHOLAR AGAD TANTRA DEPARTMENT
Affiliation	Pt Khushilal Sharma Government Auto College And Institute Bhopal Madhya Pradesh
Address	Room no 228 PG Department of Agad Tantra Evum Vidhi Vaidyaka Pt Khushilal Sharma Government Auto College And Institute Bhopal Madhya Pradesh Bhopal MADHYA PRADESH 462003 India
Phone	9755347489
Fax
Email	sisodiyakirti96@gmail.com

Details of Contact Person
Scientific Query

Name	DR DEEPIKA THAKUR
Designation	LECTURER OF AGAD TANTRA DEPARTMENT
Affiliation	Pt Khushilal Sharma Government Auto College And Institute Bhopal Madhya Pradesh
Address	Room no 228 PG Department of Agad Tantra Evum Vidhi Vaidyaka Pt Khushilal Sharma Government Auto College And Institute Bhopal Madhya Pradesh Bhopal MADHYA PRADESH 462003 India
Phone	8143449578
Fax
Email	deepika.smiling@gmail.com

Details of Contact Person
Public Query

Name	DR DEEPIKA THAKUR
Designation	LECTURER OF AGAD TANTRA DEPARTMENT
Affiliation	Pt Khushilal Sharma Government Auto College And Institute Bhopal Madhya Pradesh
Address	Room no 228 PG Department of Agad Tantra Evum Vidhi Vaidyaka Pt Khushilal Sharma Government Auto College And Institute Bhopal Madhya Pradesh Bhopal MADHYA PRADESH 462003 India
Phone	8143449578
Fax
Email	deepika.smiling@gmail.com

Source of Monetary or Material Support

Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal Madhya Pradesh

Primary Sponsor

Name	Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal Madhya Pradesh
Address	Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal Madhya Pradesh
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
Nil	Nil

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Kirti Sisodiya	Pt Khushilal Sharma Government Autonomous Ayurveda College And Institute Bhopal Madhya Pradesh	Deparatment Of Agad Tantra Evum Vidhi Vaidyaka science hills Behind Manit Kolar Nehru Nagar Bypass Road Bhopal Madhya Pradesh 462003 Bhopal MADHYA PRADESH	9755347489 sisodiyakirti96@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Pt. Khushilal Sharma Govt (Auto) Ayurveda College And Institute Bhopal Institutional Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:N898\|\|Other specified noninflammatory disorders of vagina. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, Abnormal Vaginal Discharge,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Arkadi Varti, Reference: Charak Chikitsa, Route: Vaginal, Dosage Form: Varti/ Suppository, Dose: 2(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -

Inclusion Criteria

Age From	21.00 Year(s)
Age To	60.00 Year(s)
Gender	Female
Details	1. Patient having complain of abnormal vaginal discharge 2. Patients of age group between 21 to 60 years of age . 3. Subjects willing to participate in the study ready to give consent & for P/S(per speculum), P/V(per vaginal) examination .

ExclusionCriteria

Details

1.Patients who are virgin.
2.Pregnant, postpartum and lactating women.
3.Patients who will be suffering from any systemic illnesses.
4.Malignant & premalignant lesion of genitals.
5.Patient having any kind drug hypersensitivity history.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Healthy Vaginal Environment	15 Days After Giving Intervention

Secondary Outcome

Outcome	TimePoints
To Improve Quality Of Life	15 Days

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

Phase 2/ Phase 3

Date of First Enrollment (India)

01/12/2023

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="1"
Months="6"
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

In INDIA, about 55.6% of women are suffered from abnormal vaginal discharge. . Majority of the women experienced whitish vaginal discharge (76.3%) and 49.6% along with foul & fish smelling discharge. Thus presence of a high level of abnormal vaginal discharge is of significant public health concern. As Calotropis procera is one of those drug of Ayurveda having potency to cure the abnormal vaginal discharge due to the properties of chemical constitution.