FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/06/068323 [Registered on: 04/06/2024] Trial Registered Prospectively
Last Modified On: 31/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Yoga for Primary Dysmenorrhea among Adolescent girls of Ranchi Jharkhand 
Scientific Title of Study   To Study the Effect of Yoga on Menstrual Distress among Adolescent Girls with Primary Dysmenorrhea: A Randomized Controlled Trial in Ranchi, Jharkhand 
Trial Acronym  Not Applicable 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Apoorva Wasnik 
Designation  Junior Resident Academics 
Affiliation  Rajendra Institute of Medical Sciences 
Address  Department of PSM, 4th floor, Rajendra Institute of Medical Sciences, Ranchi

Ranchi
JHARKHAND
834009
India 
Phone  9907639993  
Fax    
Email  apoorva51191@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Mithilesh Kumar  
Designation  Additional Professor 
Affiliation  Rajendra Institute of Medical Sciences, Ranchi 
Address  Department of PSM, 4th Floor, Rajendra Institute of Medical Sciences, Ranchi, Jharkhand

Ranchi
JHARKHAND
834009
India 
Phone  9835808310  
Fax    
Email  mithilesh2576@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mithilesh Kumar  
Designation  Additional Professor 
Affiliation  Rajendra Institute of Medical Sciences, Ranchi 
Address  Department of PSM, 4th Floor, Rajendra Institute of Medical Sciences, Ranchi

Ranchi
JHARKHAND
834009
India 
Phone  9835808310  
Fax    
Email  mithilesh2576@gmail.com  
 
Source of Monetary or Material Support  
Rajendra Institute of Medical Sciences, Ranchi 834009 Jharkhand India 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [nil] 
 
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 Apoorva Wasnik  Tikait Umrao Singh Sheikh Bhikhari Project Balika High School  Indoor room 1, Shastri Block Chowk, Ormanjhi, Ranchi, 835219
Ranchi
JHARKHAND 
9907639993

apoorva51191@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee RIMS Ranchi  Approved 
Tikait Umrao Singh Sheikh Bhikhari Project Balika High School  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 
Comparator Agent  No Intervention given to the Comparator group  The baseline and follow up data collection will be done from the comparator group at the starting and then again at the end of 4 months. No active intervention given to them as they naturally are not taking any treatment for the condition.  
Intervention  Yoga Asna  Following yoga asna will be given to the participants During Menstrual bleeding phase: Pranayama Yogic sukshma vyayamas/loosening exercises Marjaryasana-Bitilasana/ cat-cow pose Baddha konasana /butterfly pose Supta Baddha Konasana/ goddess pose Bhujangasan/cobra pose Balasana/child pose Yoga Nidra /Savasan Intervention will be given for 4 months period 5 times in a week for a duration of 30-40 mins daily.  
 
Inclusion Criteria  
Age From  11.00 Year(s)
Age To  17.00 Year(s)
Gender  Female 
Details  1. Adolescent girls of class 8th to 10th already attained menarche and willing to participate in the study
2. Menstrual pain grading of 3 to 8 on visual analogue scale
3. Having menstrual cycle of 24 to 38 days with regularity by which no. of days varies less than equal to 7-9 days
4. Menstrual bleeding phase of less than equal to 8 days
5. Volume of bleed less than 100 points on Pictorial Blood Assessment Chart PBAC.
 
 
ExclusionCriteria 
Details  1. Any pre diagnosed Gynecological condition leading to Secondary dysmenorrhea
2. Already performing Yogic asanas
3. Taking regular medications for Menstrual cramps
4. Any Musculo skeletal disability restricting the intervention.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in menstrual distress as measured by Menstrual Distress Questionnaire by change in Mean VAS ( Visual Analogue Scale) score after the intervention of yoga.  end of 4months of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in school absenteeism after intervention  10 months after the starting of intervention 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
Final Enrollment numbers achieved (Total)= "254"
Final Enrollment numbers achieved (India)="254" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/06/2024 
Date of Study Completion (India) 31/01/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
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
Modification(s)  

Introduction: Primary dysmenorrhea refers to cyclic menstrual pain without an identifiable underlying pathology. This common condition is characterized by cramping during menstruation, often accompanied by symptoms like low backache, nausea, vomiting, headache, or diarrhea. Prostaglandins play a role in dysmenorrhea by stimulating myometrial contractions and causing ischemia. Despite its prevalence, dysmenorrhea can significantly impact physical and mental well-being.

Empiric therapy, including NSAIDs, oral contraceptives, and other medications, is commonly used for management. Non-pharmacological approaches such as exercise, acupuncture, and yoga have also been studied. Yoga, with its holistic approach, may not only alleviate menstrual pain but also improve overall health.

The study aims to assess the effect of yoga on menstrual distress among adolescent girls suffering from primary dysmenorrhea. Additionally, it aims to address knowledge gaps related to menstrual and reproductive health in this population.

Aim: Alleviate menstrual distress and improve overall menstrual health in adolescent girls.

Primary Objective: Evaluate the impact of yoga intervention using the Menstrual Distress Questionnaire (MDQ).

Materials and Methods:

Study Design: Randomized Controlled Trial

Study Site: Government high school in Ranchi

Study Population: Adolescent girls (class 8th to 10th) with primary dysmenorrhea from government and private high schools.

Inclusion criteria:

  1. Adolescent girls of class 8th to 10th already attained menarche and willing to participate in the study
  2. Menstrual pain grading of 3 to 8 on VAS 
  3. Having menstrual cycle of 24-38 days with regularity by which no. of days varies ≤ 7-9 days
  4. Menstrual bleeding phase of ≤ 8 days
  5. Volume of bleed <100 points on Pictorial Blood Assessment Chart (PBAC)

Exclusion criteria:

  1. Any pre diagnosed Gynecological condition leading to Secondary dysmenorrhea
  2. Already performing Yogic asanas
  3. Taking regular medications for Menstrual cramps
  4. Any Musculo skeletal disability restricting the intervention.

 Sample size:

Sample Size calculation: From the previous study 

Alpha=0.05 / Z(1-α/2) = 1.96

Power=0.80/(1-β) = 0.84

Delta=0.91(μ2-μ1)

SD  (σ) = 2.67

Equating the values into the formula: [{Z(1-α/2)+Z(1-β)} × (2σ)2] / (μ2-μ1)2

 Sample Size in number:125 per group / 250 total

Method of Sample collection: Out of all the schools of the Ranchi city government  1 school will be selected by Simple Random samplingWell-informed assent will be taken from the pupils, parents and head of the school prior to the studyParticipants for the study will be selected as per eligibility criteriaRandom allocation will be done using Block Randomization for fixed block sizes into participant population/ Intervention group and non- participant / control groupbase line data by pre tested questionnaire will be collected from both the groups. Yoga as an intervention will be given to the intervention group for 3 months period 5 times in a week for a duration of 30-40 mins daily depending on the phase of menstrual cycle the participants are in (according to pre designed verified yoga protocol) preferably at the same time of the day.

Yoga given during menstrual bleeding phase

Pranayama

3 min

Yogic sukshma vyayamas/loosening exercises

3 min

Marjaryasana-Bitilasana/ cat-cow pose

5 min

Baddha konasana /butterfly pose

5 min

Supta Baddha Konasana/ goddess pose

5 min

Bhujangasan/cobra pose

5 min

Balasana/child pose

5min

Yoga Nidra /Savasan

6min

 

  • Yoga will be instructed by a certified instructor and 
  • a detailed booklet of all the asanas to be performed will be distributed to each participant. Participants will be instructed in the presence of school teachers/ PTs, accuracy of yoga being done will be checked fortnightly by the instructor. Investigator will be monitoring the intervention 2 to 3 times a week to check the regularity.
  • End point data with the same questionnaire will be collected after the end of 4th month of intervention at all the phases individually.
  • Rescue treatment for the participants will be provided if the pain or other complications arise during the course of intervention and the particular participant will be excluded from analysis.

   Data collection and Statistical analysis:

Both pre-intervention and post-intervention data will be collected. Baseline characteristics of both the group will be compared, drop out, lost to follow-up will be assessed.  Per protocol, analysis will be done. All necessary tests of significance will be applied to prove the findings statistically significant.

Data entry and record will be maintained in Excel sheets using MS Excel and data analysis will be done by IBM SPSS software version 20.0

 
Close