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CTRI Number  CTRI/2023/03/050476 [Registered on: 09/03/2023] Trial Registered Prospectively
Last Modified On: 07/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   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 
Scientific Title of Study   Effectiveness of selected Yogic techniques with sapthasaram kashaya to sapthasaram kashaya alone in pain & associated symptoms of primary dysmennorhoea for 3 months among working women aged 18-35 years -A Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Smitha Mary Shine 
Designation  Assistant Professor 
Affiliation  Govt Ayurveda College,Trivandrum 
Address  Department of Swasthavritta Govt Ayurveda College Trivandrum Kerala

Thiruvananthapuram
KERALA
695001
India 
Phone  9446315549  
Fax    
Email  smithamaryshine@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Jayan D 
Designation  Professor 
Affiliation  Govt Ayurveda College,Trivandrum 
Address  Department of Swasthavritta Govt Ayurveda College Trivandrum Kerala

Thiruvananthapuram
KERALA
695001
India 
Phone  9447104383  
Fax    
Email  dr.jayan.d@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Smitha Mary Shine 
Designation  Assistant Professor 
Affiliation  Govt Ayurveda College,Trivandrum 
Address  Department of Swasthavritta Govt Ayurveda College Trivandrum Kerala

Thiruvananthapuram
KERALA
695001
India 
Phone  9446315549  
Fax    
Email  smithamaryshine@yahoo.co.in  
 
Source of Monetary or Material Support  
Government Ayurveda Medical College Thiruvananthapuram  
 
Primary Sponsor  
Name  Government Ayurveda Medical College Thiruvananthapuram  
Address  Dr Smitha Mary Shine Assistant Professor Department of Swasthavritta Govt Ayurveda College Trivandrum Kerala 
Type of Sponsor  Other [Government Ayurveda Medical College Thiruvananthapuram ] 
 
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 JAYAN D  Govt Ayurveda Panchakarma Hospital ,Pujapura  Department of Swasthavritta Govt Ayurveda College Trivandrum Kerala
Thiruvananthapuram
KERALA 		 9447104383

smithamaryshine@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,Govt Ayurveda College,Thiruvananthapuram  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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: sapthasaram kashaya, Reference: sahasrayoga-gulma chikitsa, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -hingu), Additional Information: -
2Intervention ArmProcedure-Asana,Pranayama,Kapalabhathi,Meditation,Sapthasaram kashaya (Procedure Reference: yoga, Procedure details: asana,pranayama,kapalabhathi,meditation)
(1) Medicine Name: sapthasaram kashaya, Reference: sahasrayoga-gulmachikitsa, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 48(ml), Frequency: bd, Duration: 3 Months
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  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 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Intensity of pain
2.Duration of pain
3.Nausea
4.Vomiting
5.Irritability
6.Headache
7.Diarrhoea
8.Constipation 		 Assessment
before intervention 0th day
after the intervention 90th day
after follow up 180th day 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life assessed using Q-LES-Q-SF  Quality of life assessed
before intervention on 0th day
after intervention on 90th day
after follow up on 180 th day 
 
Target Sample Size   Total Sample Size="212"
Sample Size from India="212" 
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 3 
Date of First Enrollment (India)   10/03/2023 
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="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Dysmenorrhoea is painful menstruation which incapacitate her day to day activities.Udavartha Yoni vyapath mentioned in Ayurveda resembles primary dysmenorrhea.Randomized Controlled Trail will be done.106 working women with moderate to severe primary dymenorrhoea each will be randomly allocated into study and control groups by allocation concealment.Group 1 will be given selected Yogic techniques-from 5th day of each menstrual cycle namely Asanas ,Pranayama, Sadkarma, Meditation. Yoga will be continued for 3 consecutive months. Each month 10 sachets of 48 g Sapthasaram kashaya churna with 5 gm of hingu will be provided for both groups. Each month both groups has to prepare 98ml Sapthasaram kashaya with 500 mg hingu as anupana and has to take kashaya 7 days prior  to menstruation and on 3 days of menstruation. Sapthasara kashaya with hingu will be continued for 3 consecutive months.The pain and associated symptoms of Primary  dysmenorrhoea in both groups will be assessed BT,AT,AF on 0th day,90th day,180th day. The change in Quality of life in both groups will be assessed BT,AT,AF on 0th day,90th day,180th day.The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)  a 16 item self-administered questionnaire that captures life satisfaction over the past week will be used to assess QOL.Statistical analysis will be done using appropriate statistical tests-  Comparison of quantitative variables between two group will be analyzed by Unpaired t test or Mann Whitney U test according to the nature of the data.  Comparison of qualitative variables between two group will be analyzed by Chi square test.  Data analysis will be performed using SPSS version 16.  Analysis of variance (R M ANOVA) will be used to assess any differences in Q‐LES‐Q‐SF scores   

  
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