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CTRI Number  CTRI/2025/01/079570 [Registered on: 27/01/2025] Trial Registered Prospectively
Last Modified On: 19/12/2024
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   Ayurvedic management of pain during periods  
Scientific Title of Study   A single blind randomized comparative clinical trial to evaluate the efficacy of Panchkola Arka and Chaturbeeja Arka in the management of Udavartini Yonivyapad (Primary 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  DR SHIVANI SHARDA 
Designation  PG SCHOLAR 
Affiliation  Shri dhanwantry ayurvedic college and hospital 
Address  ROOM NO A-205,DEPARTMENT OF PRASUTI TANTRA EVUM STREE ROGA,SHRI DHANWANTRY AYURVEDIC COLLEGE AND HOSPITAL SEC 46B CHANDIGARH
chandigarh
Chandigarh
CHANDIGARH
160047
India 
Phone  8745000070  
Fax    
Email  dr.shivanisharma@outlook.com  
 
Details of Contact Person
Scientific Query  
Name  DR HARPREET 
Designation  PROFESSOR  
Affiliation  Shri Dhanwantry Ayurvedic College And Hospital 
Address  ROOM NO A-205, DEPARTMENT OF PRASUTI TANTRA EVUM STREE ROGA, SHRI DHANWANTRY AYURVEDIC COLLEGE AND HOSPITAL SEC 46B CHANDIGARH
Chandigarh
Chandigarh
CHANDIGARH
160047
India 
Phone  9417039027  
Fax    
Email  harpreet.minni@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR HARPREET 
Designation  PROFESSOR 
Affiliation  Shri Dhanwantry Ayurvedic College And Hospital 
Address  ROOM NO A-205, DEPARTMENT OF PRASUTI TANTRA EVUM STREE ROGA, SHRI DHANWANTRY AYURVEDIC COLLEGE AND HOSPITAL SEC 46B CHANDIGARH
Chandigarh
Chandigarh
CHANDIGARH
160047
India 
Phone  9417039027  
Fax    
Email  harpreet.minni@gmail.com  
 
Source of Monetary or Material Support  
SHRI DHANWANTRY AYURVEDIC COLLEGE AND HOSPITAL SECTOR 46B CHANDIGARH PIN CODE 160047 INDIA 
 
Primary Sponsor  
Name  DR SHIVANI SHARDA 
Address  ROOM NO A-205,SHRI DHANWANTRY AYURVEDIC COLLEGE AND HOSPITAL SEC 46B CHANDIGARH PIN CODE 160047,INDIA 
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 SHIVANI SHARDA  SHRI DHANWANTRY AYURVEDIC COLLEGE AND HOSPITAL SEC 46B CHANDIGARH  ROOM NO 105,FIRST FLOOR,DEPARTMENT OF PRASUTI TANTRA EVUM STREE ROGA
Chandigarh
CHANDIGARH 		 8745000070

dr.shivanisharma@outlook.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE SHRI DHANWANTRY AYURVEDIC COLLEGE AND HOSPITAL SECTOR 46-B,CHANDIGARH  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: Chaturbeeja Arka, Reference: Arka Prakash, Route: Oral, Dosage Form: Arka, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Guda), Additional Information: -5 days prior to onset of mensturation upto 2nd day of periods for 3 consecutive cycles
2Intervention ArmDrugClassical(1) Medicine Name: Panchkola Arka, Reference: Arka Prakash, Route: Oral, Dosage Form: Arka, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Guda), Additional Information: - 5 days prior to onset of mensturation till 2nd day of periods
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Female 
Details  Subjects fulfilling the diagnostic criteria Subjects of Age group 18 to 30 years Married and unmarried women Subjects with regular menstrual cycles with the interval of 24 to 38 days History of painful menstruation for atleast 3 consecutive cycles Subjects without any structural pelvic pathology 
 
ExclusionCriteria 
Details  Subjects experiencing menstrual pain attributed to underlying pelvic pathology diagnosed by USG like uterine fibroids adenomyosis endometriosis etc Subjects with Intrauterine contraceptive devices IUCDs Subjects with uncontrolled diabetes hypothyroidism and hypertension Subjects with a history of undiagnosed irregular vaginal bleeding
Subjects who habitually consume analgesics antispasmodics sedatives or muscle relaxants within 48 hours before expected menstrual periods
Subjects on Progesterone or Estrogen Pills
Subjects with any structural pelvic pathology
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
80 % reduction in scoring of WALIDD
 		 from 0th to 90th day
 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in associated symptoms  from 0th to 90th day 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   05/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  05/02/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
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  

Primary Dysmenorrhea is the most common gynaecological problem that faced by women during their adolescence and is a common problem of the females in the reproductive age group. It is the spasmodic pain that confined to the lower abdomen and may radiate to the back and medial aspects of thighs without any pelvic pathology. Primary dysmenorrhea can be correlated with Udavartini Yonivyapad of Acharya Charaka or Udavarta of Acharya Sushruta.This trial is to evaluate and compare the efficacy of Panchkola Arka and Chaturbeeja Arka in the management of Udavartini Yonivyapad (Primary Dysmenorrhea). The trial will be performed in two groups one will be given Panchkola Arka and second will be given Chaturbeeja Arka .To avoid biasness investigator will be blinded in the study hence it a single blind study. Both the arka will be given in 10ml bd dose from 5 days prior to mensturation till 2nd day of periods. The observation and result will be analysed statistically with relevant tests and level of significance will be reported .Primary outcome will be - Reduction in scoring of WALIDD,80 % of reduction (Baseline and 3rd menstrual cycle) and secondary expected outcome will be: Reduction in associated symptoms i.e.  nausea, vomiting, headache etc.

 
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