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CTRI Number  CTRI/2024/05/066715 [Registered on: 03/05/2024] Trial Registered Prospectively
Last Modified On: 22/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Study the effect of Chaturbeeja Churana Ghanvati in Primary Dysmenorrhea (Udavartini Yonivyapad) 
Scientific Title of Study   A Single Arm Clinical Study to Evaluate the Efficacy Of Chaturbeeja Churna Ghanvati in The Management of Primary Dysmenorrhea (Udavartini Yonivyapad ) 
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 Bharti 
Designation  PG Scholar 
Affiliation  Dr D Y Patil College of Ayurved and Research Centre 
Address  OPD No 2 Department of Stri Roga and Prasuti Tantra Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune

Pune
MAHARASHTRA
411018
India 
Phone  9873265057  
Fax    
Email  bharti.gahlawat1992@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pradnya Shirke 
Designation  Professor 
Affiliation  Dr D Y Patil College of Ayurved and Research Centre 
Address  OPD No 2 Department of Stri Roga and Prasuti Tantra Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune

Pune
MAHARASHTRA
411018
India 
Phone  9623446110  
Fax    
Email  pradnyashirke2@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pradnya Shirke 
Designation  Professor 
Affiliation  Dr D Y Patil College of Ayurved and Research Centre 
Address  OPD No 2 Department of Stri Roga and Prasuti Tantra Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune


MAHARASHTRA
411018
India 
Phone  9623446110  
Fax    
Email  pradnyashirke2@gmail.com  
 
Source of Monetary or Material Support  
Dr D Y Patil College of Ayurveda and Research Centre 
 
Primary Sponsor  
Name  Dr Bharti 
Address  Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune Maharashtra 411018 
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 Bharti  Dr D Y Patil College of Ayurveda and Research Centre   OPD No 2 Department of Stri Roga and Prasuti Tantra Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune 411018
Pune
MAHARASHTRA 
09873265057

bharti.gahlawat1992@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DR. DYPCA & RC INSTITUTIONAL ETHICS COMMITTEE  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: YONIROGAH/YONI-VYAPADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Chaturbeeja Churana, Reference: Bhavprakash, Haritakyadi varga 6/88-89, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: -
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  25.00 Year(s)
Gender  Female 
Details  1.Patient’s suffering from Painful menstruation for more than 3 consecutive cycles.
2.Age groups between 12 to 25 years shall be selected (Inclusive of both Years) 
 
ExclusionCriteria 
Details  1.Known case of Secondary dysmenorrhea.
2.Any pelvic pathology like Fibroid, Adenomyosis, Ovarian tumors, Endometriosis, Pelvic inflammatory disease.
3.Women diagnosed with congenital anomalies of reproductive tract, pelvic infections.
4.Other medical disorders which make patient at high risk- like Epilepsy, Anaemia Hb less than 9gm/dl, Heart disease, Diabetes.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of Chaturbheeja Churna Ghanvati in the management of Dysmenorrohea on the bais of VAS Scale and WaLIDD Scale for Pain.  7 days before menstrual cycle upto three days during menstrual cycle for 3 consecutive menstrual cycles 
 
Secondary Outcome  
Outcome  TimePoints 
To study other effects of Chaturbeeja Churna Ghanvati in Primary Dysmenorrhoea, If any.  7 days before menstrual cycle upto three days during menstrual cycle for 3 consecutive menstrual cycles 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   13/05/2024 
Date of Study Completion (India) 22/06/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 22/06/2025 
Estimated Duration of Trial   Years="1"
Months="6"
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)  

Menstruation, conception & motherhood are the creative aspects of procreation. Among them, menstruation is one of the physiological process seen in reproductive phase, which denotes the healthy state of female reproductive system. Dysmenorrhea is the Greek terminology defined as painful menstruation of sufficient magnitude so as to incapacitate day to day activities. It may be categorized into two types:- 1)Primary Dysmenorrhea 2)Secondary dysmenorrhea . Primary dysmenorrhea is painful menses in women with normal pelvic anatomy usually begins during adolescence.  It is characterized by crampy pelvic pain beginning shortly before or at the onset of menses and lasting 1-3days. The pain is of spasmodic in nature that usually confined to lower abdomen and may radiate to the back and legs. Systemic discomfort like nausea, vomiting, fatigue, giddiness, diarrhea, headache may be associated. In Ayurveda, primary dysmenorrhea can be correlated with Udavartini Yonivyapada which is characterized by painful menstruation. Udavartini is derived from Udavarta, that is upward direction of vayu. Charka first described Udavartini in Vataja nanatmaja diseases. He also elaborated the same in chikitsasthana. Rajas gets pushed in upward direction due to the pratiloma Gati of Apana Vayu because of obstruction in the normal flow in Pakwashaya,that is  the chief site of Apana vayu itself.  Menstrual pain of primary dysmenorrhea now become more prevalent because of the lifestyle and dietary habits. With a prevalence of more than 70% primary dysmenorrhea is becoming the most common gynecological problem impacting daily activities of women especially teenage girls. Today’s dietary habits and lifestyle also contribute to the increasing incidence of dysmenorrhea. Primary dysmenorrhea is not a real threat of life but can greatly  affect ones quality of life.

The Aim of study is to evaluate the efficacy of Chaturbeeja Churana Ghanvati in Primary Dysmenorrhea ( Udavartini Yonivyapad). Total 40 Patients will be enrolled and 1 gram of Chaturbeeja Churana Ghanvati will be given with dosage of 2 tablets of 250mg twice a day. the age group taken for the study will be from 12 years to 25 Years old Menstruating Women.

 
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