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effectiveness of Asana,Pranayama ,Kapalabhathi,meditation & Sapthasaram kashaya to Sapthasara kashaya alone in reducing the pain & associated symptoms of painful menstruation among working women aged 18-35 years

Phase 3
Not yet recruiting
Conditions
Primary dysmenorrhea. Ayurveda Condition: UDAVARTINI,
Registration Number
CTRI/2023/03/050476
Lead Sponsor
Government Ayurveda Medical College Thiruvananthapuram
Brief Summary

Dysmenorrhoea is painful menstruation whichincapacitate her day to day activities.UdavarthaYoni vyapath mentioned in Ayurveda resembles primary dysmenorrhea.RandomizedControlled Trail will be done.106 working women withmoderate to severe primary dymenorrhoea each will be randomly allocated intostudy and control groups by allocation concealment.Group1 will be given selected Yogic techniques-from 5th day of eachmenstrual cycle namely Asanas ,Pranayama, Sadkarma, Meditation. Yoga will becontinued for 3 consecutive months. Each month 10 sachets of 48 g Sapthasaram kashaya churnawith 5 gm of hingu will be provided for both groups. Each month both groups hasto prepare 98ml Sapthasaram kashaya with 500 mg hingu as anupana and has totake kashaya 7 days prior  tomenstruation and on 3 days of menstruation. Sapthasara kashaya with hingu willbe continued for 3 consecutive months.The pain and associated symptoms of Primary  dysmenorrhoea in both groups will be assessedBT,AT,AF on 0th day,90th day,180th day. The change in Quality of life in bothgroups will be assessed BT,AT,AF on 0th day,90th day,180thday.TheQuality of Life Enjoyment and Satisfaction Questionnaire - Short Form(Q-LES-Q-SF)  a 16 item self-administeredquestionnaire that captures life satisfaction over the past week will be usedto assess QOL.Statisticalanalysis will be done using appropriate statistical tests-  Comparisonof quantitative variables between two group will be analyzed by **Unpaired ttest** or **Mann Whitney U test** according to the nature of the data.  Comparisonof qualitative variables between two group will be analyzed by **Chi squaretest**.  Dataanalysis will be performed using SPSS version 16.  **Analysis of variance (R M ANOVA)** will be used to assess anydifferences in Qâ€LESâ€Qâ€SF scores

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
Female
Target Recruitment
212
Inclusion Criteria

1.working women with moderate to severe painful menstruation without any evident pelvic pathology 2.working women in age group 18-35 years 3.working women with at least 4 painful menstrual cycles during previous months 4.having informed consent from institution and from patient 5.subjects having regular menstrual cycles.

Exclusion Criteria

1.subjects who are not willing to do yoga 2.subjects with known cases of PID, DUB, any pelvic pathology 3.subjects with known cases of severe systemic illness and anatomical defects 4.subjects on oral contraceptive pillls 5.subjects having irregular menstrual cycle 6.subjects having malignancy.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
8.ConstipationAssessment | before intervention 0th day | after the intervention 90th day | after follow up 180th day
1.Intensity of painAssessment | before intervention 0th day | after the intervention 90th day | after follow up 180th day
2.Duration of painAssessment | before intervention 0th day | after the intervention 90th day | after follow up 180th day
3.NauseaAssessment | before intervention 0th day | after the intervention 90th day | after follow up 180th day
4.VomitingAssessment | before intervention 0th day | after the intervention 90th day | after follow up 180th day
7.DiarrhoeaAssessment | before intervention 0th day | after the intervention 90th day | after follow up 180th day
5.IrritabilityAssessment | before intervention 0th day | after the intervention 90th day | after follow up 180th day
6.HeadacheAssessment | before intervention 0th day | after the intervention 90th day | after follow up 180th day
Secondary Outcome Measures
NameTimeMethod
Quality of life assessed using Q-LES-Q-SFQuality of life assessed

Trial Locations

Locations (1)

Govt Ayurveda Panchakarma Hospital ,Pujapura

🇮🇳

Thiruvananthapuram, KERALA, India

Govt Ayurveda Panchakarma Hospital ,Pujapura
🇮🇳Thiruvananthapuram, KERALA, India
DR JAYAN D
Principal investigator
9447104383
smithamaryshine@yahoo.co.in

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