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CTRI Number

CTRI/2019/06/019810 [Registered on: 21/06/2019] Trial Registered Prospectively

Last Modified On:

20/06/2019

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Ayurvedic treatment on Polycystic ovary

Scientific Title of Study

A Comparative clinical study to evaluate the efficacy of Shatapushpa Churna and Shatavari Churna in Aartavadushti With Special Reference to Polycystic Ovarian Syndrome

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	DR BHAKTI MANE
Designation	PG SCHOLAR
Affiliation	YMT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL
Address	ROOM NO. 1, HANUMAN CHAWL, CHITTALSAR MANPADA, GHODBUNDER ROAD, OPPOSITE HANUMAN TEMPLE, DURGA CHOWK, THANE(WEST) YMT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL, INSTITUTIONAL AREA, SECTOR-4, KHARGHAR, NAVI MUMBAI â€“ 410210 Raigarh MAHARASHTRA 400607 India
Phone	9867252231
Fax
Email	bhaktiyogeshjanwalkar@gmail.com

Details of Contact Person
Scientific Query

Name	DR PRANALI DANDEKAR
Designation	ASSOCIATE PROFESSOR
Affiliation	YMT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL
Address	YMT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL, INSTITUTIONAL AREA, SECTOR-4, KHARGHAR, NAVI MUMBAI Raigarh MAHARASHTRA 410210 India
Phone	9619020010
Fax
Email	pranalibhardwaj@gmail.com

Details of Contact Person
Public Query

Name	DR PRANALI DANDEKAR
Designation	ASSOCIATE PROFESSOR
Affiliation	YMT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL
Address	YMT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL, INSTITUTIONAL AREA, SECTOR-4, KHARGHAR, NAVI MUMBAI Raigarh MAHARASHTRA 410210 India
Phone	9619020010
Fax
Email	pranalibhardwaj@gmail.com

Source of Monetary or Material Support

ROOM NO. 1, HANUMAN CHAWL, CHITTALSAR MANPADA, GHODBUNDER ROAD, OPPOSITE HANUMAN TEMPLE, DURGA CHOWK, THANE(WEST) -400607

YMT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL, INSTITUTIONAL AREA, SECTOR-4, KHARGHAR, NAVI MUMBAI â€“ 410210

Primary Sponsor

Name	DR BHAKTI MANE
Address	ROOM NO. 1, HANUMAN CHAWL, CHITTALSAR MANPADA, GHODBUNDER ROAD, OPPOSITE HANUMAN TEMPLE, DURGA CHOWK, THANE(WEST) -400607
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
DR BHAKTI MANE	YMT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL	3RD FLOOR , STREEROG PRASUTITANTRA DEPARTMENT . YMT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL, INSTITUTIONAL AREA, SECTOR-4, KHARGHAR, NAVI MUMBAI â€“ 410210 Raigarh MAHARASHTRA	9867252231 bhaktiyogeshjanwalkar@gmail.com

Details of Ethics Committee

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

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: E282\|\|Polycystic ovarian syndrome,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Shatapushpa Churna	Shatapushpa Churna (1karsha) 12 gm OD (pratahakala) will be given with goghrita to group A for 3 months.
Comparator Agent	Shatavari Churna	Shatavari Churna (1karsha) 12 gm OD (pratahakala) will be given with goghrita to group B for 3 months.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	40.00 Year(s)
Gender	Female
Details	Women between 18-40 years both married and unmarried. All cases of PCOS having amenorrhoea and / oligomenorrhoea. PCOS patients having signs of hyperandrogenism. Presence of polycystic ovaries by ultrasound. a)Presence of multiple >12 follicular cysts measuring about 2-9mm in diameter. b)Ovarian volume is increased >10cm3.

ExclusionCriteria

Details

Uterine fibroid, polyp, adenomyosis, tubercular endometriosis, ovarian mass and tumour. K/C/O Diabetes Mellitus, hypertension, thyroid.
Congenital adrenal hyperplasia; Congenital absence or deformities of uterus and ovaries. Patients having congenital anamolies in female genital tract
Pregnant women

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Shatapushpa Churna is more effective in comparison with Shatavari Churna in menstrual regulisation PCOS.	PATIENT WILL BE FOLLOWED UP ONCE A MONTH FOR 3 CONSEQUENT MONTHS.

Secondary Outcome

Outcome	TimePoints
Shatapushpa Churna is not effective in comparison with Shatavari Churna in menstrual regulisation in PCOS.	PATIENT WILL BE FOLLOWED UP ONCE A MONTH FOR 3 CONSEQUENT MONTHS.

Target Sample Size

Total Sample Size="64"
Sample Size from India="64"
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)

22/06/2019

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

NIL

Individual Participant Data (IPD) Sharing Statement

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

Brief Summary

TITLE:

A Comparative clinical study to evaluate the efficacy of Shatapushpa Churna and Shatavari Churna in Aartavadushti With Special Reference to Polycystic Ovarian Syndrome

TRIAL DRUG: Shatapushpa Churna

CONTENTS: Shatapushpa

ASSESSMENT CRITERIA:

Assessment will be made on change in clinical features before and after treatment. To assess menstruation

To assess volume of ovary To assess hormonal changes

SUBJECTIVE CRITERIA:

The patients undergoing the treatment will be assessed on the basis of symptoms rating score depicted below for improvement in specific symptoms of PCOS.

1. MENSTRUATION:

IMP (DAYS)	GRADE	SCORE
28 days	Nil	0
28-45 days	Mild	1
45-60 days	Moderate	2
Above 60 days	Severe	3

2.ASSESSMENT OF OVARIAN VOLUME:

OVARIAN VOLUME	SCORE
5-10	0
10-15	1
15-20	2
>20	3

3.DURATION OF MENSTRUAL FLOW:

DAYS	SCORE
3-5	0
<3	1
<2	2
<1	3

4.QUANTITY OF MENSTRUAL BLOOD:

GRADE 0	2 pad used
GRADE 1	1 pad used
GRADE 2	Spotting with pads
GRADE 3	0 pad used (no menstrual blood even spotting)

OBJECTIVE CRITERIA:

USG-volume of ovary

Sr.LH

Sr.FSH

Sr.Testosterone

FINAL ASSESSMENT:

In view of changes in grade of clinical features,it was declared as follows-

Complete cure 100% free from chief complaint (irregular,scanty and heavy menstruation revert back to normal menstruation)

Maximum improvement-75% to < 100% improvement of the clinical features. Moderate improvement-50% to < 75% improvement of the clinical features. Mild improvement-25% to < 50% improvement of the clinical features.

No improvement- <25% or no improvement in both subjective and objective parameters.