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CTRI Number  CTRI/2024/02/062406 [Registered on: 07/02/2024] Trial Registered Prospectively
Last Modified On: 07/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of Chaturbeeja choorna in the management of primary dysmenorrhoea i.e., painful menstruation. 
Scientific Title of Study   An open label single arm clinical study on the effect of Chaturbeeja choorna in the management of Udavartini Yonivyapath vis-à-vis 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 Anushree A B C 
Designation  PG Scholar 
Affiliation  JSS Ayurveda Medical College And Hospital 
Address  JSS Ayurveda Medical College and Hospital, Lalithadripura Road, Mysuru - 570028

Mysore
KARNATAKA
570028
India 
Phone  8762023925  
Fax    
Email  anushreesagar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nanda K O 
Designation  Assistant Professor  
Affiliation  JSS Ayurveda Medical College And Hospital 
Address  Department Of PG Studies in Prasooti Tantra And Stree Roga, JSS Ayurveda Medical College And Hospital, Lalithadripura Road, Alanahalli, Mysuru

Mysore
KARNATAKA
570028
India 
Phone  8970322532  
Fax    
Email  nandadeepak.dr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nanda K O 
Designation  Assistant Professor  
Affiliation  JSS Ayurveda Medical College And Hospital 
Address  Department Of PG Studies in Prasooti Tantra And Stree Roga, JSS Ayurveda Medical College And Hospital, Lalithadripura Road, Alanahalli, Mysuru

Mysore
KARNATAKA
570028
India 
Phone  8970322532  
Fax    
Email  nandadeepak.dr@gmail.com  
 
Source of Monetary or Material Support  
JSS Ayurveda Medical College and Hospital 
 
Primary Sponsor  
Name  Dr Anushree A B C 
Address  Department of PG Studies in Prasooti Tantra and Stree Roga, JSS Ayurveda Medical College and Hospital, Lalithadripura road, Alanhalli, Mysuru. 
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 Anushree A B C   JSS Ayurveda Medical College and Hospital  Department of PG Studies in Prasooti Tantra and Stree Roga, OPD no 9
Mysore
KARNATAKA 
8762023925

anushreesagar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JSS Ayurveda Medical College and Hospital  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
1Intervention ArmDrugClassical(1) Medicine Name: chaturbeeja churna, Reference: bhavaprakasha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -sukoshnajala), Additional Information: -5 days prior cycle and during cycle for 3 months
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  32.00 Year(s)
Gender  Female 
Details  Patients with regular cycles complaining of painful menstruation for at least 3 consecutive cycles. 
 
ExclusionCriteria 
Details  Pelvic pathology - known case of fibroid, adenomyosis, endometriosis, pelvic inflammatory disease, menorrhagia, malignancy.
Patients with intrauterine contraceptive devices or on contraceptive pills
Congenital anomalies of reproductive systems
Metabolic disorders - known case of diabetes mellites, hypertension, thyroid dysfunction.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To know the effect of Chaturbeeja choorna in the management of Primary Dysmenorrhoea.  3 consecutive cycles follow up will be done on each cycle the assessment of any improvement in objective and subjective parameters will be assessed .  
 
Secondary Outcome  
Outcome  TimePoints 
The effect of drug on over all development & improvement pertaining general condition & haemoglobin levels will be assessed   3 consecutive cycles follow up will be done on each cycle the assessment of any improvement in objective & subjective parameters will be assessed .  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   07/03/2024 
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="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

ü  Dysmenorrhea is the most common gynecological problem faced by women during their reproductive period which causes significant discomfort and anxiety for the women as well as her family.

ü  A systemic review of studies from India reported the prevalence range between 50-87.8% in developing countries performed by Agarwal & Agarwal (2010) have revealed that about 25-50% of adult women and about 75% of adolescents experience pain during menstruation, with 5-20% reporting severe dysmenorrhea or pain that prevent them from ensuing day-to-day activities.1

ü  In Udavartini Yonivyapath vitiation of Apana Vata is considered as primary cause as there’ll be Urdvagamana of Vata therefore the line of treatment is to ensure Vatanulomana and Vatahara action. So the  easily available and cost effective drug Chaturbeeja Choorna is chosen due to its Vatanulomana and Vatahara action, therefore Udavartini Yonivyapath management is achieved.2,3

ü  In modern system NSAID are often prescribed in the treatment of dysmenorrhea. During menstruation, many women experience gastrointestinal discomforts which are increased by analgesics and anti-inflammatory drugs, which also produce headache, dizziness, drowsiness and blurred vision. The role of hormones (estrogens-progesterone or contraceptive pills) as a prolonged therapeutic measure especially on unmarried girls for dysmenorrhea is itself debatable. So there is a great scope of research to find out management which is effective, to treat the entire feature complex with single regimen and find out the treatment for the underlying pathology from Ayurveda for the management of Udavartini Yonivyapath.

 
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