CTRI

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CTRI Number

CTRI/2024/09/074467 [Registered on: 27/09/2024] Trial Registered Prospectively

Last Modified On:

24/09/2024

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda
Preventive

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Ayurvedic Management of Irregular menses PCOD

Scientific Title of Study

Comparative Clinical Evaluation of Shatpushpa Kalpa and Krishna Tila Kwatha in Pushpaghni Jatahrini w.s.r to PCOD/PCOS.

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 Pravesh Tomar
Designation	Associate Proffesor
Affiliation	Rishikul Campus Uttarakhand Ayurved University
Address	Opd No 9 Department of Prasuti Tantra Evam Stree Roga Uttarakhand Ayurved University, Rishikul Campus Haridwar Hardwar UTTARANCHAL 249401 India
Phone	9870899895
Fax
Email	praveshtomarlal@rediffmail.com

Details of Contact Person
Scientific Query

Name	Dr Pravesh Tomar
Designation	Associate Proffesor
Affiliation	Rishikul Campus Uttarakhand Ayurved University
Address	Opd No 9 Department of Prasuti Tantra Evam Stree Roga Uttarakhand Ayurved University, Rishikul Campus Haridwar UTTARANCHAL 249401 India
Phone	9870899895
Fax
Email	praveshtomarlal@rediffmail.com

Details of Contact Person
Public Query

Name	Dr Nidhi Palariya
Designation	PG Scholar
Affiliation	Rishikul Campus Uttarakhand Ayurved University
Address	Opd No 9 Department of Prasuti Tantra Evam Stree Roga Uttarakhand Ayurved University, Rishikul Campus Haridwar Hardwar UTTARANCHAL 249401 India
Phone	08755371082
Fax
Email	nidhi.palariya97@gmail.com

Source of Monetary or Material Support

Pg Department of Prasuti Tantra Evam Stree Roga OPD No 9 Rishikul Campus Uttarakhand Ayurved University Haridwar Uttarakhand India 249201

Primary Sponsor

Name	Rishikul Campus Uttarakhand Ayurved University
Address	PG Department of Prasuti Tantra Evam Stree Roga OPD No 9 Rishikul Campus Uttarakhand Ayurved University Haridwar Uttarakhand India 249401
Type of Sponsor	Government medical college

Details of Secondary Sponsor

Name	Address
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 Nidhi Palariya	Rishikul Campus Uttarakhand Ayurved University	Opd No 9 Department of Prasuti Tantra Evam Stree Roga Uttarakhand Ayurved University, Rishikul Campus Haridwar Hardwar UTTARANCHAL	08755371082 nidhi.palariya97@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Instituitional Ethics Committee Uttarakhand Ayurved University, Rishikul Campus Haridwar	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. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Shatpushpa kalpa, Reference: Kashyapa Samhita Shatpushpa Kalpaadhyay, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Gau ghrita), Additional Information: The drug is to be taken in kalpa form starting from 6gm up to 42 gm at an interval of 6 days for 45 days then decrease from 42 gm to 6gm at an interval of 6 days for 45 days
2	Comparator Arm	Drug	Classical		(1) Medicine Name: Krishna Tila Kwatha, Reference: Yoga Ratnakar Yoni Vyapad Chikitsa, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Guda), Additional Information: -

Inclusion Criteria

Age From	15.00 Year(s)
Age To	40.00 Year(s)
Gender	Female
Details	1 Female patients of Age between 15yrs to 40 yrs 2 In USG presence of multiple small cysts follicle and Increased Ovarian volume 3 Patient fulfilling the diagnostic criteria ASRM or ESHRE 2003 A Oligo and or anovulation B Hyperandrogenism clinical and or biochemical C Polycystic ovaries Ovarian volume more than 10 cm3 a Multi follicular cyst more than 12 b Cyst Size 2mm to 9mm in diameter

ExclusionCriteria

Details

1 Female of age group less than 15 years or more than 40 years
2 Patient has gross structural abnormalities of uterus and appendages
3 Those had primary amenorrhea
4 Pelvic disease like Fibroids, benign or malignant tumors of ovary, STDs, PID etc
5 Patient with IUCD
6 Systemic disease- bleeding disorder, diabetes mellitus, hypertension, tuberculosis etc

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

Not Applicable

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Improvement in Duration of Bleeding Amount of Bleeding and Interval of Menstruation Mild Improvement in Acne	1 month

Secondary Outcome

Outcome	TimePoints
Regular menstrual cycle in the Interval of 28 to 30 Days Improvement in Amount & Duration of bleeding Reduction in hyperpigmentation & Acne Improvement in Body Mass index	3 months

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

Phase 2/ Phase 3

Date of First Enrollment (India)

10/10/2024

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

PCOD/PCOS is the significant health challenges affecting women, especially teenagers and those of reproductive age causing menstrual irreguralities, hirsutism and obesity which in ayurved according to its symptoms can be correlated to pushpaghni jataharini. The present study is designed to establish effective management of PCOS/PCOD by comparative study between Shatpushpa kalpa and krishna tila kwatha fpr three consecutive month. The drugs selected for present thesis work are purely ayurvedic in origin easily available and economic.