CTRI

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CTRI Number

CTRI/2024/04/066481 [Registered on: 29/04/2024] Trial Registered Prospectively

Last Modified On:

27/04/2024

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda
Screening
Behavioral

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Ayurvedic intervention in severe grade Pre menstrual syndrome

Scientific Title of Study

A randomized double blind comparative clinical trial to evaluate the efficacy of Vacha ( acorus calamus linn.) churna versus Shunthi (zingiber officinale roscoe.) churna in severe grade Premenstrual Syndrome

Trial Acronym

PMS- Premenstrual Syndrome

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	kajal
Designation	PG Scholar
Affiliation	Shri Dhanwantry Ayurvedic College and Hospital
Address	Room no 105 A Shri Dhanwantry Ayurvedic college and Hospital Sector 46B Chandigarh Chandigarh CHANDIGARH 110047 India
Phone	8607483938
Fax
Email	kajalthind67@gmail.com

Details of Contact Person
Scientific Query

Name	Archana s
Designation	Associate professor
Affiliation	Shri Dhanwantry Ayurvedic College and Hospital
Address	Room no 205 A Shri Dhanwantry Ayurvedic college and Hospital Sector 46B Chandigarh Room no 105 A Shri Dhanwantry Ayurvedic college and Hospital Sector 46B Chandigarh Chandigarh CHANDIGARH 110047 India
Phone	8607483938
Fax
Email	archanas875@gmail.com

Details of Contact Person
Public Query

Name	kajal
Designation	PG Scholar
Affiliation	Shri Dhanwantry Ayurvedic College and Hospital
Address	Room no 205 A Shri Dhanwantry Ayurvedic college and Hospital Sector 46B Chandigarh Chandigarh CHANDIGARH 110047 India
Phone	8607483938
Fax
Email	kajalthind67@gmail.com

Source of Monetary or Material Support

Shri Dhanwantry Ayurvedic College and Hospital Sector 46 B Chandigarh 160047

Primary Sponsor

Name	Shri Dhanwantry Ayurvedic College and Hospital Sector 46 B Chandigarh
Address	Sector 46 B Chandigarh 160047
Type of Sponsor	Private medical college

Details of Secondary Sponsor

Name	Address
kajal	Shri Dhanwantry Ayurvedic College and Hospital Sector 46 B Chandigarh

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 S	Shri Dhanwantry Ayurvedic College and Hospital Chandigarh	Prasuti and Stree Roga OPD Room No 105 Shri Dhanwantry Ayurvedic College and Hospital Sector 46 B Chandigarh Chandigarh CHANDIGARH	7986521986 archanas875@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethical committee Shri Dhanwantry Ayurvedic college and hospital	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:E280\|\|Estrogen excess. Ayurveda Condition: PMS,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: vacha, Reference: tang hridyam uttarsthanam Adhyaya 39 verse 162 -163, Route: Oral, Dosage Form: Churna/ Powder, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -), Additional Information: -
2	Comparator Arm	Drug	Other than Classical		(1) Medicine Name: shunthi, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -leukwarm water), Additional Information: -

Inclusion Criteria

Age From	18.00 Year(s)
Age To	25.00 Year(s)
Gender	Female
Details	Regular menstrual cycle of 21-35 days,Unmarried women age between 18-25years Able to sign consent form and cooperative behavior Severe grade PMS And PMDD Criteria (as per ICD 11 and DSM-V) Symptoms Exist More Than 2 Cycles

ExclusionCriteria

Details

Irregular cycle
Symptoms exists less than 2 cycles
History of any drug addiction
Patients participating in any other clinical trial 1 month back
Currently breastfeeding, pregnant
Ovariectomy, abortion, contraceptive usage within 6 months
Any history of mental disorder or patient on medication for that
Any systemic disorder like hypothyroidism , heart disease, kidney disease , circulatory system disease, malignant disease
Any history of allergic to any drug Pelvic pathology diagnosed with USG if any

Method of Generating Random Sequence

Random Number Table

Method of Concealment

An Open list of random numbers

Blinding/Masking

Participant and Investigator Blinded

Primary Outcome

Outcome	TimePoints
Change in the total score of PMS assessed with DRSP scale	Baseline 1st 2nd 2and 3rd cycle

Secondary Outcome

Outcome	TimePoints
Change in the total score of mood behavioral and physical symptoms separately with DRSP Scale Improvement in Quality of Life(WHO QOL) -(baseline,3rd cycle)	Baseline,1st,2nd,and 3rd cycle)

Target Sample Size

Total Sample Size="72"
Sample Size from India="72"
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

Date of First Enrollment (India)

10/05/2024

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="0"
Months="4"
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

Title: A randomized double blind comparative clinical trial to evaluate the efficacy of Vacha (Acorus calamus Linn.)churna versus Shunthi (Zingiber officinale Roscoe.) churna in severe grade Premenstrual Syndrome

Abstract:

Introduction: Pre-menstrual syndrome (PMS) and pre-menstrual dysphoric disorder (PMDD) are characterized by cyclic physical, mental, and behavioral changes in women, with PMDD being a more severe form. While the exact cause remains unclear multiple biochemical abnormalities have been implicated. Ayurveda, although lacking direct reference to PMS provides insights into menstrual cycle phases and dosha imbalances. This study aims to evaluate the efficacy of Vacha churna compared to Shunthi churna in managing severe PMS symptoms

Methods: A randomized, double-blind, controlled trial will be conducted at Dhanwantry Ayurvedic College and Hospital, Chandigarh. Seventy-two unmarried women aged 18-25 years with severe PMS/PMDD will be enrolled and randomized into two groups receiving either Vacha churna or Shunthi churna for three menstrual cycles. Outcome measures include subjective criteria assessed through the Daily Record of Severity of Problems (DRSP) scale and the WHO Quality of Life scale along with objective criteria such as weight change. Statistical analysis will be performed using SPSS-21

Results: Primary outcomes will include changes in total PMS scores and sub-scores for mood, behavioral, and physical symptoms. Secondary outcomes will focus on improvements in quality of life. Expected results will be based on inter-group analysis using independent samples t-tests.

Conclusion: This study aims to provide evidence regarding the efficacy of Vacha churna in managing severe PMS symptoms compared to Shunthi churna. If successful, it could offer an alternative treatment option with minimal side effects and better patient acceptance.

Keywords: Pre-menstrual syndrome, Pre-menstrual dysphoric disorder, Vacha churna, Shunthi churna, Ayurveda, Randomized controlled trial.