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CTRI Number  CTRI/2024/08/072107 [Registered on: 08/08/2024] Trial Registered Prospectively
Last Modified On: 07/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effect of dipyadi churna in patients with primary dysmenorrhoea. 
Scientific Title of Study   A randomised controlled clinical trial to study the effect of dipyadi Churna In udavartini yonivyapada with special reference to primary dysmenorrhoea.  
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 Priyanka Madan Nagargoje  
Designation  PG student  
Affiliation  SMBT Ayurved College and Hospital Dhamangaon Nashik  
Address  Department of prasuti tantra evum stri roga SMBT ayurved college and hospital Dhamangaon Nashik MAHARASHTRA 422403 India

Nashik
MAHARASHTRA
422403
India 
Phone  9673125994  
Fax    
Email  piyanagargoje1208@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prashant Subhash Patil 
Designation  Associate professor  
Affiliation  SMBT Ayurved College and Hospital Dhamangaon Nashik  
Address  Department of prasuti tantra evum stri roga SMBT ayurved college and hospital Dhamangaon Nashik MAHARASHTRA 422403 India

Nashik
MAHARASHTRA
422403
India 
Phone  9923601819  
Fax    
Email  drpp210@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Priyanka Madan Nagargoje  
Designation  PG student  
Affiliation  SMBT Ayurved College and Hospital Dhamangaon Nashik  
Address  Department of prasuti tantra evum stri roga SMBT ayurved college and hospital Dhamangaon Nashik MAHARASHTRA 422403 India

Nashik
MAHARASHTRA
422403
India 
Phone  9673125994  
Fax    
Email  piyanagargoje1208@gmail.com  
 
Source of Monetary or Material Support  
SMBT ayurved college and hospital dhamangaon nashik nashik- 422403 Maharashtra India 
 
Primary Sponsor  
Name  Dr Priyanka Madan Nagargoje  
Address  SMBT ayurved college and hospital Dhamangaon Nashik  
Type of Sponsor  Other [Self] 
 
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 Priyanka Madan Nagargoje   SMBT Ayurved college and hospital Dhamangaon Nashik   OPD no 4 Department of prasuti tantra evum stri roga Dhamangaon Nashik Nashik Maharashtra
Nashik
MAHARASHTRA 		 9673125994

piyanagargoje1208@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMBT Ayurved college and hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N00-N99||Diseases of the genitourinary system. Ayurveda Condition: UDAVARTINI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Dipyadi churna, Reference: Bruhad nighantu Ratnakar , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: -koshnajal ), Additional Information: -
2Comparator Arm (Non Ayurveda)-Mefenamic acid Mefenamic acid 500mg during menses (sos)
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  25.00 Year(s)
Gender  Female 
Details  1) Patient suffering from the symptom like unbearable pain in lower abdomen during menstrual cycles
2) school and college going girls between age 13 to 25 years
3) Patients having regular menstrual cycle with normal amount of menstrual flow (normal 2-3pad/day)  
 
ExclusionCriteria 
Details  1) Patients with secondary dysmenorrhea 2) Patients with IUCD 3) Patient taking contraceptive pills  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in sign and symptoms of udavartini yonivyapad after giving dipyadi churna  18months  
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable   Not applicable  
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   18/08/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   Prevalence rate of primary dysmenorrhoea is70.2%.Primary dysmenorrhoea is confined to adolescents.The incidence of primary dysmenorrhoea of sufficient magnitude to incapicitation is 15-20%. In modern science first line choice therapy for primary dysmenorrhoea is NSAIDs.They are highly effective, but have their own side effects if used for longer period.The primary treatment for udavartini yonivyapada is vatashaman. Dipyadi churna has properties like vatanuloman,vatashaman,shoolprashaman.As previously no study has been done on dipyadi churna in Udavartini yonivyapada ,so it will be helpful in female between age group 13 to 25 years having sign and symptoms of primary dysmenorrhoea such as painful menstruation,nausea, vomiting suprapubic and lumbosacral pain.Written informed consent will be taken to ensure compliance and transperancy in research process.The sample size calculated 35 in each group by Daniel formula1999.Simple random sampling technique will be used.Total 70 number of patients will be divided into two groups as group A(trial group)and group B(control group). Dipyadi churna to group A and Mefenamic acid to group B.All SOP of churna will be followed throughout the clinical trial.Observation will be done after menstrual cycle.Result will be drawn on the basis of assessment criteria statistical Discussion will be done on the basis of observation and result obtained during treatment.Summary will be drawn,and thesis will be summarised with the help of statistical analysis.Conclusion will be drawn. 
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