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临床试验/CTRI/2024/01/061698
CTRI/2024/01/061698已完成2 期

Combined Effect of Pomegranate Juice and Cold Hip Bath on Primary Dysmenorrhea A Pilot Study

SVYASA University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年1月27日最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
changes in pain intensity checked through visual analogue scale

研究概览

简要总结

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

Group 2Pomegranate 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

1monthfollow 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

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 25.00 Year(s)(—)
性别
Female

入选标准

  • Age between 18 to 25 years female college students will be included based On MSQ Scale mild to moderate scoring females will be included.

排除标准

  • subjects will be excluded if They have irregular menstrual cycle Secondary dysmenorrhea or Any Comorbidities.

结局指标

主要结局

changes in pain intensity checked through visual analogue scale

时间窗: 3 time points | prior to the study | immediately after the study | one month after follow up

次要结局

  • changes in quality of life checked through Euro QOL 5 dimension 5 level questionnaire(3 time points)

研究者

发起方
SVYASA University
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Swathi B S

Swami Vivekananda Yoga Anusandhana Samsthana

研究点 (1)

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