CTRI

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CTRI Number

CTRI/2025/08/093211 [Registered on: 19/08/2025] Trial Registered Prospectively

Last Modified On:

03/09/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda
Preventive

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

EFFECT OF TRIKATUKADI CHURNA IN PRIMARY DYSMENORRHEA

Scientific Title of Study

A CONTROLLED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF TRIKATUKADI CHURNA OVER HINGWADI CHURNA IN THE MANAGEMENT OF UDAVARTINI YONIVYAPAD W.S.R TO PRIMARY DYSMENORRHEA

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 ARCHANA G N
Designation	PG SCHOLAR
Affiliation	Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre
Address	OPD DEPARTMENT OF PRASUTI TANTRA EVAM STREE ROGA GROUND FLOOR SDM TRUSTS AYURVEDIC MEDICAL COLLEGE DANIGOND POST GRADUATION CENTRE PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE DR SIDDHANT NAGAR TERDAL SDM TRUSTS AYURVEDIC MEDICAL COLLEGE DANIGOND POST GRADUATE CENTRE AND PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE DR SIDDHANT NAGAR TERDAL 587315 Bagalkot KARNATAKA 587315 India
Phone	7019486050
Fax
Email	archanagn10@gmail.com

Details of Contact Person
Scientific Query

Name	DR P K RAWAL
Designation	PROFESSOR AND HOD
Affiliation	Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre
Address	OPD DEPARTMENT OF PRASUTI TANTRA EVAM STREE ROGA GROUND FLOOR SDM TRUSTS AYURVEDIC MEDICAL COLLEGE DANIGOND POST GRADUATION CENTRE AND PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE DR SIDDHANT NAGAR TERDAL 587315 SDM TRUSTS AYURVEDIC MEDICAL COLLEGE DANIGOND POST GRADUATE CENTRE AND PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE DR SIDDHANT NAGAR TERDAL 587315 Bagalkot KARNATAKA 587315 India
Phone	9880976151
Fax
Email	Chaitanya.rawal5@gmail.com

Details of Contact Person
Public Query

Name	DR ARCHANA G N
Designation	PG SCHOLAR
Affiliation	Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre
Address	OPD DEPARTMENT OF PRASUTI TANTRA EVAM STREE ROGA GROUND FLOOR SDM TRUSTS AYURVEDIC MEDICAL COLLEGE DANIGOND POST GRADUATION CENTRE PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE DR SIDDHANT NAGAR TERDAL 587315 SDM TRUSTS AYURVEDIC MEDICAL COLLEGE DANIGOND POST GRADUATE CENTRE AND PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE DR SIDDHANT NAGAR TERDAL 587315 Bagalkot KARNATAKA 587315 India
Phone	7019486050
Fax
Email	archanagn10@gmail.com

Source of Monetary or Material Support

SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar Terdal 587315 Bagalkot Karnataka

Primary Sponsor

Name	DR ARCHANA G N
Address	SDM TRUSTS AYURVEDIC MEDICAL COLLEGE DANIGOND POST GRADUATE CENTRE AND PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE DR SHIDDHANT NAGAR TERDAL 587315 BAGALKOT KARNATAKA INDIA
Type of Sponsor	Other [SELF]

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 Archana G N	Padma Ayurvedic Hospital And Research Centre	OPD Department of Prasuti Tantra Evum Stree Roga Ground Floor Padma Ayurvedic Hospital And Research Centre 587315 Bagalkot KARNATAKA	7019486050 archanagn10@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
SDM TRUST AYURVEDIC MEDICAL COLLEGE AND PADMA AYURVEDIC HOSPITAL INSTITUTIONAL ETHICS COMMITEE FOR RESEARCH ON HUMAN SUBJECTS	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:N944\|\|Primary dysmenorrhea. Ayurveda Condition: UDAVARTINI,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Comparator Arm	Drug	Classical		(1) Medicine Name: Hingwadi Churna , Reference: P V Sharma, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: Sukhoshna jala), Additional Information: 5 days for 3 consecutive cycles
2	Intervention Arm	Drug	Classical		(1) Medicine Name: Trikatukadi Churna, Reference: Sahasra Yoga, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: Sukhoshna jala), Additional Information: 5 days for 3 consecutive cycles

Inclusion Criteria

Age From	15.00 Year(s)
Age To	35.00 Year(s)
Gender	Female
Details	1 Patients of age between 15-35 years. 2 Patients complaining painful menstruation for atleast 2 consecutive cycle. 3 Pratyatma Lakshana of Udavartini Yonivyapad. 4 Patient willing to sign the consent form.

ExclusionCriteria

Details

1 K/C/O–Fibroid Uterus, PID, Carcinoma of endometrium, Menorrhagia, Endometriosis, Adenomyosis.
2 K/C/O – Systemic diseases like DM, HTN and Thyroid.
3 K/C/O – Congenital anomaly.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Not Applicable

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Effect of trial drug on improvement in classical symptoms of Udavartini Yonivyapad (Primary Dysmenorrhea)	6th day of 1st menstrual cycle, 6th day of 2nd menstrual cycle, 6th day of 3rd menstrual cycle

Secondary Outcome

Outcome	TimePoints
Safety of the trial drug and adverse drug reaction and aggravation in the symptoms of Udavartini yonivyapad(Primary Dysmenorrhea)	6th day of 1st menstrual cycle, 6th day of 2nd menstrual cycle, 6th day of 3rd menstrual cycle

Target Sample Size

Total Sample Size="40"
Sample Size from India="40"
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 3

Date of First Enrollment (India)

30/08/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

30/08/2025

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)
Modification(s)

Not Yet Recruiting

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details
Modification(s)

N/A

Individual Participant Data (IPD) Sharing Statement

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

Response - NO

Brief Summary
Modification(s)

Primary dysmenorrhea is a common, disregarded, underdiagnosed and inadequately treated complaint which slows down the women in her day to day activity and has a major impact on women’s quality of life, work productivity and healthcare utilization.The prevalence of dysmenorrhea varies between 16% - 91% in women of reproductive age with severe pain in 2% - 29% of the women studied. Udavartini Yonivyapad caused due to movement of Vata in upward direction (Udavartana) caused by Vatakopa due to Vegadharana or functional disturbance or secondary to obstruction of Vata further causing pain and displacement of rajas which is expelled with great difficulty.

In Modern system of medicine, non-addictive analgesics are prescribed in the primary dysmenorrhea which includes NSAID’S, Hormonal treatment and Anti-spasmodic drugs. In this scenario rather than hormonal treatment, Ayurvedic herbo-mineral treatment is proved to be effective in Udavartini Yonivyapad. Keeping this in mind to find a suitable remedy which will be gentle, non-hormonal safe and effective alternate in the management of Dysmenorrhea. The main Dosha causing Udavartini Yonivyapad is Vata. Trikatukadi Churna⁴ and Hingwadi Churna⁵ is having Anulomana, Vatakapha Hara and Shoola Prashamanaproperties. So here is an attempt to evaluate and compare the efficacy of trial drug Trikatukadi Churna and control drug of Hingwadi Churna in the management of Udavartini Yonivyapad w.s.r to Primary Dysmenorrhea.