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CTRI Number  CTRI/2025/02/081052 [Registered on: 21/02/2025] Trial Registered Prospectively
Last Modified On: 18/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of Hingwadi Vati in the management of Udavartini Yonivyapad w.s.r Dysmenorrhea 
Scientific Title of Study   A Clinical study to evaluate the efficacy of Hingwadi Vati in the management of Udavartini Yonivyapad w.s.r to Dysmenorrhea  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shambhawi Singh  
Designation  Post Graduate Scholar  
Affiliation  Government Ayurvedic College and Hospital Kadamkuan Patna Bihar 
Address  Department of Prasuti tantra Evum Stree Roga Government Ayurvedic College and Hospital Kadamkuan Patna Bihar 800003

Patna
BIHAR
800003
India 
Phone  8210688047  
Fax    
Email  shambhawisingh2101@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prabha Kumari  
Designation  Associate Professor and Head of Department  
Affiliation  Government Ayurvedic College and Hospital Kadamkuan Patna Bihar 
Address  Department of Prasuti tantra Evum stree roga Government Ayurvedic College and Hospital Kadamkuan Patna Bihar 800003

Patna
BIHAR
800003
India 
Phone  7004860634  
Fax    
Email  dr.prabhapandey@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Shambhawi Singh  
Designation  Post Graduate Scholar  
Affiliation  Government Ayurvedic College and Hospital Kadamkuan Patna Bihar 
Address  Department of Prasuti tantra Evum stree roga Government Ayurvedic College and Hospital Kadamkuan Patna Bihar 800003

Patna
BIHAR
800003
India 
Phone  8210688047  
Fax    
Email  shambhawisingh2101@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurvedic College and Hospital Kadamkuan Patna Bihar 800003 
 
Primary Sponsor  
Name  Government Ayurvedic College and Hospital Patna  
Address  Government Ayurvedic College and Hospital Kadamkuan Patna Bihar 800003 
Type of Sponsor  Other [Government Ayurvedic College and Hospital Patna ] 
 
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 Prabha Kumari   Government Ayurvedic College and Hospital Kadamkuan Patna   Department of Prasuti tantra Evum Stree Roga OPD room no 1 Government Ayurvedic College and Hospital Kadamkuan Patna Bihar 800003
Patna
BIHAR 		 7004860634

dr.prabhapandey@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Patna  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N946||Dysmenorrhea, unspecified. Ayurveda Condition: UDAVARTINI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Hingwadi Vati , Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -Ushna jala ), Additional Information: -Hingwadi Vati is given one week before menstruation upto cessation of menstruation.This is continued for 2 consecutive cycles
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1.Patients willing for the trial.
2. Age groups :12-35 years.
3. Patient with regular menstrual cycles.
4.Patients suffering from pain for more than 2 cycles.
5.Patients fulfilling the diagnostic criteria.  
 
ExclusionCriteria 
Details  1.Patients with irregular menstrual cycle.
2.Patients with pelvic pathology like PID,Uterine fibroid,Endometriosis,etc.
3.Patients with intrauterine contraceptive devices.
4. Patients having chronic general illness.
5.Patients having any systemic diseases like Diabetes Mellitus, Hypertension,etc. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Relief in pain calculated on the basis of VAS scale.  2 months (BT and AT) 
 
Secondary Outcome  
Outcome  TimePoints 
Relief in pain intensity,duration and associated complains  2 months (BT and AT) 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 2 
Date of First Enrollment (India)   01/03/2025 
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="0"
Months="3"
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   Dysmenorrhea is a highly prevalent gynecological problem but usually goes unnoticed .Its prevalence is around 82% in India. Although it is not life threatening but it is found to have a profound impact on day to day life activities.In ayurvedic classics it is  described under the heading of udavartini yonivyapad whose cardinal symptom is pain . According to ayurveda pain is an indication of vata vikruti thus vatanulomana measures are preferred . The orally administered drug Hingwadi vati has vata anulomana,vatahara and vednasthapan properties which will alleviate the symptoms.This is why I have chosen this drug for my study. 
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