CTRI

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CTRI Number

CTRI/2022/07/043979 [Registered on: 13/07/2022] Trial Registered Prospectively

Last Modified On:

11/07/2022

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Single Arm Study

Public Title of Study

Ayurvedic approach for Female Infertility (Stree Bandhyatva) Nehakukreti

Scientific Title of Study

To Evaluate The Role of Vat Shung Nasya in Ovulatory Factor of Female Infertility (Stree Bandhyatva)

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Neha Kukreti
Designation	Research Scholar
Affiliation	Rishikul Campus UAU Haridwar
Address	Department of Prasuti Tantra Evam Stree Roga Rishikul Campus Haridwar Uttarakhand Ayurveda University Department of Prasuti Tantra Evam Stree Roga OPD NO 9 Rishikul Campus Haridwar Uttarakhand Ayurveda University Harrawala Dehradun Hardwar UTTARANCHAL 249401 India
Phone	8923368201
Fax
Email	nehakukreti.nk@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Hem Prakash
Designation	Professor
Affiliation	Uttarakhand Ayurveda University Rishikul Campus
Address	Department of Prasuti Tantra Evam Stree Roga Rishikul Campus Haridwar Uttarakhand Ayurveda University Department of Prasuti Tantra Evam Stree Roga OPD NO 9 Rishikul Campus Haridwar 249401 Uttarakhand Ayurveda University Harrawala Dehradun Hardwar UTTARANCHAL 249401 India
Phone	9456346224
Fax
Email	hemprakash78@gmail.com

Details of Contact Person
Public Query

Name	Dr Hem Prakash
Designation	Professor
Affiliation	Uttarakhand Ayurveda University Rishikul Campus
Address	Department of Prasuti Tantra Evam Stree Roga Rishikul Campus Haridwar Uttarakhand Ayurveda University Department of Prasuti Tantra Evam Stree Roga OPD NO 9 Rishikul Campus Haridwar 249401 Uttarakhand Ayurveda University Harrawala Dehradun Hardwar UTTARANCHAL 249401 India
Phone	9456346224
Fax
Email	hemprakash78@gmail.com

Source of Monetary or Material Support

Rishikul Campus Haridwar

Primary Sponsor

Name	Dr Neha Kukreti
Address	P.G Department of Prasuti Tantra Evam Stree Roga Rishikul Campus Uttrakhand Ayurveda University Haridwar 249401
Type of Sponsor	Other [self]

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
neha kukreti	Rishikul Campus Haridwar Uttrakhand UAU Haridwar	PG Department of Prasuti Evam Stree Roga Rishikul Campus Haridwar Uttrakhand UAU Haridwar Hardwar UTTARANCHAL	8923368201 nehakukreti.nk@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:N970\|\|Female infertility associated withanovulation. Ayurveda Condition: female infertility, (2) ICD-10 Condition:N970\|\|Female infertility associated withanovulation. Ayurveda Condition: stree bandhayatva,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Vat Shung Nasya, Reference: sushrut samhita, Route: Nasal, Dosage Form: Swaras/ Juice, Dose: 4(drops), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: gau dugdh), Additional Information: Nasya Karma after one day of cessation of menstruation In each month for 3 consecutive cycles

Inclusion Criteria

Age From	20.00 Year(s)
Age To	40.00 Year(s)
Gender	Female
Details	1. Married female patients of childbearing age(20-40years)having infertility with the husband normal Semenogram. 2.Primary & Secondary are both types of infertility due to the ovulatory factor defect.

ExclusionCriteria

Details

1.Patient having congenital anomaly of genital tract.
2.Patient suffering from acute and chronic medical and systemic diseases like Anemia (Hb%<10gm/dl) Jaundice Hypertension Diabetes mellitus T.B Heart disease Thyroid Dysfunction Diseases of Nasal cavity other than indications of Nasya and any other debilitating disease.
3. Patients having pelvic diseases such as fibroids and ovarian cysts (>3cm).
4. Patient having malignancies.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Improvement of ovulatory factor defects .	3 months

Secondary Outcome

Outcome	TimePoints
Improvement of ovulatory factor defects and conceptions	1 Year

Target Sample Size

Total Sample Size="40"
Sample Size from India="40"
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)

15/07/2022

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="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

nil

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Female infertility due to ovulatory factor I have chosen this topic to study the effect of Vat Shung Nasya on the ovulatory factor, of female infertility.,i.e Stree Bandhyatva. drug administered through Nasa goes up to the brain and stimulates its functions.