CTRI

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CTRI Number

CTRI/2023/05/052902 [Registered on: 19/05/2023] Trial Registered Prospectively

Last Modified On:

18/05/2023

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Single Arm Study

Public Title of Study

This is the clinical study to know the effect of Palashapushpa darbhamula churna in pervaginal bleeding

Scientific Title of Study

A clinical study to evaluate the efficacy of Palashapushpa darbhamula churna in rakta pradara w.s.r to DUB- A single group study

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	Rakshitha KS
Designation	P. G Scholar
Affiliation	Alvas Ayurveda Medical College Vidyagiri Moodbidari
Address	Department of PG studies in Prasooti tantra and stree roga Alvas ayurveda medical college Moodbidri Dakshina Kannada KARNATAKA 574227 India
Phone	7019317207
Fax
Email	ksrakshitha32@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Kavitha BK
Designation	Associate Professor
Affiliation	Alvas Ayurveda Medical College Vidyagiri Moodbidari
Address	Department of PG studies in Prasooti tantra and stree roga Alvas ayurveda medical college Moodbidri Dakshina Kannada KARNATAKA 574227 India
Phone	9008979169
Fax
Email	drkavithapradeep@gmail.com

Details of Contact Person
Public Query

Name	Rakshitha KS
Designation	P. G Scholar
Affiliation	Alvas Ayurveda Medical College Vidyagiri Moodbidari
Address	Department of PG studies in Prasooti tantra and stree roga Alvas ayurveda medical college Moodbidri Dakshina Kannada KARNATAKA 574227 India
Phone	7019317207
Fax
Email	ksrakshitha32@gmail.com

Source of Monetary or Material Support

Alvas ayurveda medical college and hospital Vidyagiri Moodbidri Dakshina kannada Karnataka 574227

Primary Sponsor

Name	Rakshitha KS
Address	P. G Scholar Alvas Ayurveda Medical College and Hospital Moodbidari Dakshina kannada-574227
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
Rakshitha KS	Alvas ayurveda medical college	Department of Prasooti tantra and stree roga opd Alvas ayurveda medical college Vidyagiri Moodbidri Dakshina Kannada KARNATAKA	7019317207 ksrakshitha32@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional clinical ethical committee Alvas ayurveda medical college	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:N926\|\|Irregular menstruation, unspecified. Ayurveda Condition: Rakta pradara, (2) ICD-10 Condition:N921\|\|Excessive and frequent menstruation with irregular cycle. Ayurveda Condition: Raktapradara, (3) ICD-10 Condition: N921\|\|Excessive and frequent menstruation with irregular cycle,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Palashapushpa Darbhamula churna, Reference: Rasatantra sara va siddha prayoga sangraha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: -

Inclusion Criteria

Age From	20.00 Year(s)
Age To	45.00 Year(s)
Gender	Female
Details	1.Patient fulfilling 2 or more diagnostic criteria(Raja atipravrthi,Deergakalanubandhi,Anruthavalpamapi,Angamarda and vedana) 2.Patient having excessive bleeding/prolonged bleeding/intermenstrual bleeding with history of minimum of 2 cycles

ExclusionCriteria

Details

1.Patient with diagnosed case of Coagulation disorders, Hypertension, Diabetes mellitus, Thyroid dysfunction, Liver disease.
2.Patients having Hb% below 8gm%.
3.Post Abortal bleeding.
4.Patient with Intrauterine Contraceptive devices and Oral Contraceptive pills.
5.known case of organic and pelvic pathologies.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
The changes in the symptoms before and after the medication will be scored as follows: Pictorial Blood Assessment Chart (PBAC) scoring. Pain will be assessed by VAS grading (visual analogue scale)	During treatment- on 4th day, 7th day and 10th day. After treatment- on 8th day of 3rd menstrual cycle.

Secondary Outcome

Outcome	TimePoints
post interventional assessment will be done. Symptoms will be graded and score will be given accordingly.	1 month

Target Sample Size

Total Sample Size="30"
Sample Size from India="30"
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)

27/05/2023

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="0"
Months="3"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

Not yet

Individual Participant Data (IPD) Sharing Statement

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

Response - NO

Brief Summary

This is the interventional single group clinical study To evaluate the efficacy of Palashapuspa Darbhamula Churna in Raktapradara w. s. r to DUB for 2 consecutive menstrual cycle for 10 days in 30 patients will be conducted in Alvas Ayurveda Medical Collage and Hospital Moodbidari Camps and Other referral.