Ayurvedic treatment on Polycystic ovary

Not yet recruiting

• Conditions: Polycystic ovarian syndrome,

• Registration Number: CTRI/2019/06/019810
• Lead Sponsor: DR BHAKTI MANE

Brief Summary

TITLE:

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



TRIAL DRUG: *Shatapushpa Churna*

*CONTENTS:*Shatapushpa



ASSESSMENTCRITERIA:

Assessment willbe made on change in clinical features before and after treatment. To assessmenstruation

To assess volumeof ovary To assess hormonal changes

 SUBJECTIVE CRITERIA:The patientsundergoing the treatment will be assessedon the basis of symptomsrating score depicted belowfor 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.ASSESSMENTOF 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 ofovary

Sr.LH

Sr.FSH

Sr.Testosterone

FINAL ASSESSMENT:In view of changes in grade ofclinical features,it was declared as follows-

Complete cure100% free from chief complaint (irregular,scanty and heavy menstruation revertback to normal menstruation)

Maximumimprovement-75% to < 100% improvement of the clinical features. Moderateimprovement-50% to < 75% improvement of the clinical features. Mildimprovement-25% to < 50% improvement of the clinical features.

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

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-06-20
• Study Start: 2019-06-22

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 64

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

YMT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL; 🇮🇳 Raigarh, MAHARASHTRA, India

YMT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL

🇮🇳Raigarh, MAHARASHTRA, India

DR BHAKTI MANE

Principal investigator

9867252231

bhaktiyogeshjanwalkar@gmail.com