CTRI

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CTRI Number

CTRI/2022/11/047112 [Registered on: 07/11/2022] Trial Registered Prospectively

Last Modified On:

08/11/2022

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study
Modification(s)

Process of Care Changes

Study Design

Other

Public Title of Study

Effect of brief episodes of ischaemia-reperfusion applied in distant tissues ,on endothelial dysfunction ( a type coronary artery disease) in women with polycystic ovarian syndrome

Scientific Title of Study

Effect of Remote Ischemic Pre-conditioning (RIPC) on Endothelial Dysfunction in Women with Polycystic Ovary Syndrome(PCOS)

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	Dr Utkarsh Dwivedi
Designation	Junior Resident
Affiliation	Department of obstetrics and gynaecology
Address	Department of obstetrics and gynaecology, Institute of medical sciences,BHU Varanasi UTTAR PRADESH 221005 India
Phone	9838643416
Fax
Email	bhu350royalutkarsh@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Shikha Sachan
Designation	Associate Professor
Affiliation	Department of Obstetrics and Gynaecology
Address	Department of Obstetrics and gynaecology Institute of Medical Sciences Banaras Hindu University Varanasi UTTAR PRADESH 221005 India
Phone
Fax
Email	shikhasachan08@yahoo.com

Details of Contact Person
Public Query

Name	Dr Bhupendra Verma
Designation	Assistant Professor
Affiliation	Department of Cardiology
Address	Department of Cardiology Institute of Medical Sciences Banaras Hindu University Varanasi UTTAR PRADESH 221005 India
Phone
Fax
Email	bhupendra.269@gmail.com

Source of Monetary or Material Support

Institute of Medical Sciences, Banaras Hindu University, Varanasi

Primary Sponsor

Name	Institute of medical sciences
Address	BHU, CAMPUS VARANASI
Type of Sponsor	Government medical college

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 Utkarsh Dwivedi	Mother and child healthcare SSH BHU	1st floor, MCH wing ,Department of Obstetrics and Gynaecology, Sir Sunderlal Hospital, BHU Varanasi UTTAR PRADESH	9838643416 bhu350royalutkarsh@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional ethical committee, Faculty of Medicine, Institute of Medical Sciences, Banaras Hindu University	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: R799\|\|Abnormal finding of blood chemistry, unspecified,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Post RIPC group	intervention group will receive RIPC protocol of 4 cycles of 5 minutes each with occlusion to 220mmHg followed by 5 min re- perfusion. one intervention of 4 cycles amounting to 35 minutes will be performed daily for 7 days.
Comparator Agent	SHAM group	Sham procedure will consist of same periods as RIPC intervention but only to 40 mmHg.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	40.00 Year(s)
Gender	Female
Details	Case known of classical PCOS

ExclusionCriteria

Details

Thyroid dysfunction
Cushing syndrome
Late onset of congenital adrenal hyperplasia
Pregnancy and breastfeeding
Use of glucocorticoids, OCPs, ovulatory agents within 3 months of study
Smoking, drug and alcohol abuse

Method of Generating Random Sequence

Other

Method of Concealment

Other

Blinding/Masking

Participant Blinded

Primary Outcome

Outcome	TimePoints
maximum percentage increase in flow after cuff deflation compared to baseline flow	4 cycles of 5 minutes each with occlusion to 220 mmHg followed by 5 min re- perfusion another intervention of 4 cycles of 35 minutes daily for 7 days

Secondary Outcome

Outcome	TimePoints
nil	nil

Target Sample Size

Total Sample Size="50"
Sample Size from India="50"
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)

10/11/2022

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

We are conducting an explorative, randomized, double- blinded, SHAM- controlled trial at the outpatient clinic at the department of Gynaecology in collaboration with the Departments of Cardiology, Endocrinology and Radiology at IMS, BHU, Varanasi.

We will include 50 pre- menopausal women with classical PCOS fulfilling the inclusion and exclusion criteria as described earlier.

The patients will be randomly assigned 1:1 to RIPC (Remote Ischemic Pre- Conditioning) or SHAM group using block method once daily for 7 days . Outcome variables as described will be measured at baseline and RIPC.

The intervention group will recieve a RIPC protocol of 4 cycles of 5 minutes each with occlusion to 220 mmHg with standard sphymomanometer BP cuff on the right arm followed by 5 minutes re-perfusion . One intervention of 4 cycles amounting to 35 minutes will be performed daily for 7 days.

The SHAM procedure will consist of a pressure cuff , inflated on the right upper arm for the same periods as the RIPC intervention but only to 40 mmHg as it has shown to mimic occlusion but not limiting blood flow.