CTRI

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CTRI Number

CTRI/2025/04/085775 [Registered on: 28/04/2025] Trial Registered Prospectively

Last Modified On:

24/04/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Single Arm Study

Public Title of Study

Assessing the Effectiveness of Internal Administration of Gandharvahasthadi Yamakam in Alleviating Menstrual Pain in Females of Age Group 18-35 Years

Scientific Title of Study

Effect of Gandharvahasthadi yamakam in 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 Sneha K
Designation	PG Scholar
Affiliation	PNNM Ayurveda Medical College and Hospital,Cheruthuruthy
Address	Room no 09 Department of Prasutitantra evum Streeroga PNNM Ayurveda Medical College and Hospital, Cheruthuruthy Thrissur Thrissur KERALA 679531 India
Phone	9048385357
Fax
Email	kasyapsnehakasyap@gmail.com

Details of Contact Person
Scientific Query

Name	Dr salini P
Designation	Professor and HOD
Affiliation	PNNM Ayurveda Medical College and Hospital,Cheruthuruthy
Address	Room no 09 Department of Prasutitantra evum Streeroga PNNM Ayurveda Medical College and Hospital,Cheruthuruthy Thrissur Thrissur KERALA 679531 India
Phone	9048385357
Fax
Email	salipkavungal@gmail.com

Details of Contact Person
Public Query

Name	Dr Sithara Satheesan
Designation	Associate professor
Affiliation	PNNM Ayurveda Medical College and Hospital,Cheruthuruthy
Address	Room no 09 Department of Prasutitantra evum Streeroga PNNM Ayurveda Medical College and Hospital,Cheruthuruthy Thrissur Thrissur KERALA 679531 India
Phone	9048385357
Fax
Email	sitharasatheesan@gmail.com

Source of Monetary or Material Support

PNNM Ayurveda Medical College and Hospital,Cheruthuruthy Thrissur,Kerala,India 679 531

Primary Sponsor

Name	Dr Sneha K
Address	PNNM Ayurveda Medical College and Hospital,Cheruthuruthy Thrissur,Kerala,India 679531
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 Sneha K	PNNM Ayurveda Medical College and Hospital	Room no 09 Department of Prasutitantra evum Streeroga Thrissur KERALA	9048385357 kasyapsnehakasyap@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethical Comittee PNNM Ayurveda Medical College and Hospital	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	Intervention Arm	Drug	Classical		(1) Medicine Name: Gandharvahasthadiyamakam, Reference: Chikitsamanjari, Route: Oral, Dosage Form: Ghrita, Dose: 12(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: shoola chikitsa udhavartha chikitsa adhikara

Inclusion Criteria

Age From	18.00 Year(s)
Age To	35.00 Year(s)
Gender	Female
Details	1.Subjects with regular menstrual cycle of 28-30 days interval 2.Age group between 18-35 years 3.Subjects satisfying diagnostic criteria asper SOGC

ExclusionCriteria

Details

1.Subjects who are planning for pregnancy
2.Known case of systemic illness
3.Dysfunctional uterine bleeding
4.Structural abnormality of reproductive system
5.Lactating women
6.Pelvic pathology reported in USG
•Subjects with mandagni assessed using agnibala assessment tool
•Subjects having mridu koshta assessed using koshta assessment tool

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Reducing pain in primary dysmenorrhea	First assessment before treatment Second assessment on the 4th day of menstrual cycle after intervention Third assessment is follow-up assessment after 4 weeks

Secondary Outcome

Outcome	TimePoints
Reducing associated symptoms in primary dysmenorrhea	First assessment before treatment Second assessment on 4th day of menstrual cycle after intervention Third assessment is follow-up assessment

Target Sample Size

Total Sample Size="36"
Sample Size from India="36"
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)

10/05/2025

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 Applicable

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

This single-arm trial aims to investigate the effectiveness of Gandharvahasthadi Yamakam in alleviating the symptoms of primary dysmenorrhea in subjects aged 18-35 years .The study involves 36 participants who will be given 12ml of Gandharvahasthadi Yamakam from the 22nd day of one menstrual cycle to the 3rd day of the next cycle. Assessments will be taken before teatment, post-intervention (on the 4th day of the cycle), and at follow-up assessment (after 4 weeks) to evaluate the potential benefits of this Ayurvedic medicine in reducing pain and associated symptoms primary dysmenorrhea.