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CTRI Number  CTRI/2024/01/061698 [Registered on: 22/01/2024] Trial Registered Prospectively
Last Modified On: 01/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Combined Effect of Pomegranate Juice and Cold Hip Bath on Primary Dysmenorrhea  
Scientific Title of Study   Combined Effect of Pomegranate Juice and Cold Hip Bath on Primary Dysmenorrhea A Pilot Study 
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 Swathi B S 
Designation  Assistant professor of Diet and Nutrition  
Affiliation  Swami Vivekananda Yoga Anusandhana Samsthana 
Address  Department of diet and nutrition The school of yoga and naturopathic medicine SVYASA University prashanthi kuteeram vivekananda road Kalluballu post Anekal Taluk Jigani bangalore urban District

Bangalore
KARNATAKA
560105
India 
Phone  9480542681  
Fax    
Email  swathibs@svyasa.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Swathi B S 
Designation  Assistant professor of Diet and Nutrition  
Affiliation  Swami Vivekananda Yoga Anusandhana Samsthana 
Address  Department of Diet and Nutrition The school of yoga and naturopathy SVYASA University prashanthi kuteeram vivekananda road Kalluballu post Anekal Taluk Jigani bangalore urban District

Bangalore
KARNATAKA
560105
India 
Phone  9480542681  
Fax  9480542681  
Email  swathibs@svyasa.edu.in  
 
Details of Contact Person
Public Query
 
Name  Anushree V 
Designation  BNYS Intern  
Affiliation  Swami Vivekananda Yoga Anusandhana Samsthana 
Address  Department of diet and nutrition The school of yoga and naturopathic medicine SVYASA University prashanthi kuteeram vivekananda road Kalluballu post Anekal Taluk Jigani bangalore urban District

Bangalore
KARNATAKA
560105
India 
Phone  6362729161  
Fax    
Email  harinianu03@gmail.com  
 
Source of Monetary or Material Support  
The school of yoga and naturopathy SVYASA university Prashanti kuteeram jigani anekal karnataka 560105 
 
Primary Sponsor  
Name  SVYASA University 
Address  SVYASA University prashanthi kuteeram vivekananda road Kalluballu post Anekal Taluk Jigani bangalore urban District 
Type of Sponsor  Private medical college 
 
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 Swathi B S  The School of Yoga and Naturopathy SVYASA UNIVERSITY  Department of diet and nutrition The school of yoga and naturopathy SVYASA University prashanthi kuteeram vivekananda road Kalluballu post Anekal Taluk Jigani bangalore urban District
Bangalore
KARNATAKA 
9480542681

swathibs@svyasa.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics committee of Swami Vivekananda Yoga Anusandhana Samsthana  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N944||Primary dysmenorrhea,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cold hip bath  Would be given cold hip bath 55 to 65 degree Fahrenheit for 8minutes for 1 week prior to menstruation for consecutive 2 menstrual cycles  
Comparator Agent  Pomegranate juice and cold hip bath  Pomegranate juice 200ml will be given on empty stomach 1 week prior to menstruation followed by 3 days during menstruation along with cold hip bath 55 to 65 degree Fahrenheit for 8 minutes will be given 1 week prior to menstruation for consecutive 2 menstrual cycles 1month follow up on subsequent cycle will also be conducted 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Female 
Details  Age between 18 to 25 years female college students will be included based
On MSQ Scale mild to moderate scoring females will be included
 
 
ExclusionCriteria 
Details  subjects will be excluded if
They have irregular menstrual cycle
Secondary dysmenorrhea
or Any Comorbidities
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
changes in pain intensity checked through visual analogue scale  3 time points
prior to the study
immediately after the study
one month after follow up 
 
Secondary Outcome  
Outcome  TimePoints 
changes in quality of life checked through Euro QOL 5 dimension 5 level questionnaire   3 time points
prior to the study
immediately after the study
one month after follow up 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   27/01/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 Combined Effect of Pomegranate Juice and Cold Hip Bath on Primary Dysmenorrhea A Pilot Study

This study is a Randomized parallel group pilot study in single center trial to check the combined effect of pomegranate juice and cold hip bath on primary dysmenorrhic women primary outcome measures change in pain intensity through Visual analogue scale and Secondary outcome measures change in quality of life using Euro QOL 5 dimension 5 level questionnaire


PURPOSE OF THIS STUDY

 

Quantitative analysis shows prostaglandins levels are 13 times higher in dysmenorrhic women than non dysmenorrhic women 

Pomegranate contains ellagic acid shows to inhibit prostaglandins and According to J H Kellogg a short application of cold treatment produces tonic effect


We want to identify natural feasible and cost effective treatment to reduce pain intensity and improve quality of life in primary dysmenorrhic women 


AIM AND OBJECTIVES OF RESEARCH 

Aim 

To evaluate the efficacy of pomegranate juice along with cold hip bath on primary dysmenorrhea

Objective  

To check the efficacy cold hip bath on reducing pain intensity in primary dysmenorrhea

To check the efficacy of cold hip bath on quality of life in primary dysmenorrhea

To check the efficacy of pomegranate juice as an add on therapy along with cold hip bath on reducing pain intensity in primary dysmenorrhea

To check the efficacy of pomegranate juice as an add on therapy along with cold hip bath on quality of life in primary dysmenorrhea   

Hypothesis

Null hypothesis  is Pomegranate juice along with cold hip bath will not reduce the intensity of pain and will not improve quality of life in primary dysmenorrhea

Hypothesis Pomegranate juice helps to reduce the intensity of pain and improves quality of life in primary dysmenorrhea as an add on therapy along with cold hip bath due to its inhibitory effects on prostaglandin synthesis

METHODS

Participants

Female college students of the age group 18 to 25 with primary dysmenorrhea will be include in study subjects will be requested to fill the online consent form which also includes details about height weight medical conditions and menstrual cycle

Based on inclusion & exclusion criteria subjects will be recruited

Study design Randomized control pre and post pilot study design

Diagnostic criteria Menstrual symptom questionnaire MSQ is a 24 item self report measure which assesses menstrual pain and symptoms

The score on each item ranges from 1 never to 5 always with a higher composite score indicating more symptoms 

Inclusion criteria

Age between 18 to 25 years female college students will be included 

On MSQ Scale mild to moderate scoring females will be included

Exclusion criteria subjects will be excluded if

They have irregular menstrual cycle

 Secondary dysmenorrhea

 Any Co morbidities

Intervention

Group 1 Would be given cold hip bath 55 to 65 degree Fahrenheit for 8minutes for 1 week prior to menstruation for consecutive 2 menstrual cycles

Group 2 Pomegranate juice 200ml will be given on empty stomach 1 week prior to menstruation followed by 3 days during menstruation along with cold hip bath 55 to 65 degree Fahrenheit for 8 minutes will be given 1 week prior to menstruation for consecutive 2 menstrual cycles

1month follow up on subsequent cycle will also be conducted

Assessment

Assessment tools used in the study are Visual analogue scale VAS and Quality of life by EuroQol 5 dimensions 5 levels VAS was used to asses pain and QOL is used to assess the changes in quality of life before and after intervention 

 

 DATA ANALYSIS

Date will be collected before the onset of intervention after the completion of the study of  2 months and follow up after 1 month Tabulation of the data will be done in Excel2021 Descriptive and interferential statistics will be implied and data assessment will be done through JASP 0 16 4 software  Value of p less than 0 05 will be considered as significant 



 
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