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CTRI Number  CTRI/2025/01/079187 [Registered on: 21/01/2025] Trial Registered Prospectively
Last Modified On: 18/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To see effect of one Ayurvedic Formulation in treatment of Painful Menstruation. 
Scientific Title of Study   Randamized Controlled Clinical Trial To Evaluate The Role Of Varshabhubilwadi Kashaya In Kashtartava With Special Reference To 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 Jagruti Jagannath More  
Designation  MS Prasutitantra Evam Streerog Scholar 
Affiliation  Matoshree Asarabai Darade Ayurved College Babhulgoan ,Yeola 
Address  OPD No.8 Department of Prasutitantra evum Streerog Matoshree Asarabai Darade Ayurved College Babhulgoan Tal- yeola Dist-Nashik Pin-423401 Maharashtra India

Nashik
MAHARASHTRA
423401
India 
Phone  9518545938  
Fax    
Email  jagrutijmore@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sachin More 
Designation  Professor PG Guide Prasutitantra evum Streerog Department 
Affiliation  Matoshree Asarabai Darade Ayurved College Babhulgoan 
Address  OPD no.8 Department Of Prasutitantra evum Streerog,Matoshree Asarabai Darade Ayurved college Babhulgoan Tal-Yeola,Dist-Nashik

Nashik
MAHARASHTRA
423401
India 
Phone  9822874480  
Fax    
Email  sachinmore070979@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jagruti Jagannath More 
Designation  MS Prasutitantra Evam Streerog Scholar 
Affiliation  Matoshree Asarabai Darade Ayurved College Babhulgoan ,Yeola 
Address  OPD No.8 Department of Prasutitantra evum Streerog Matoshree Asarabai Darade Ayurved College Babhulgoan Tal- yeola Dist-Nashik Pin-423401 Maharashtra India
Matoshree Asarabai Darade Ayurved College Babhulgoan Tal- yeola Dist-Nashik Pin-423401 Maharashtra India
Nashik
MAHARASHTRA
423401
India 
Phone  9518545938  
Fax    
Email  jagrutijmore@gmail.com  
 
Source of Monetary or Material Support  
Department of Prasutitantra Evam Streerog Matoshree Asarabai Darade Ayurved College Babhulgaon Tal-Yeola Dist-Nashik Pincode-423401  
 
Primary Sponsor  
Name  Matoshree Asarabai Darade College Babhulgoan ,Yeola 
Address  Matoshree Asarabai Darade Ayurved College Babhulgoan Tal-Yeola Dist-Nashik Maharashtra India Pin-423401 
Type of Sponsor  Research institution and hospital 
 
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 Jagruti Jagannath More  Matoshree Asarabai Darade Ayurved College and Hospital Babhulgoan , Yeola  OPD No.8 Department of Prasutitantra evum Streerog
Nashik
MAHARASHTRA 		 09518545938

jagrutijmore@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Matoshree Asarabai Darade Ayurved College Babhulgoan Yeola  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: Varshabhubilwadi Kashay, Reference: Sahasrayog, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Lavana), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Female 
Details  1.Patients willing to participate in the study.
2.Patients having classical signs and symptoms of Kashtartava.
3.Females of age group 18-25 years.
4.Painful menstruation for at least 3 consecutive cycles.
5.Regular menstruation cycle ranging from 21 days to 35 days with normal bleeding 3-7 days.
6.Patients who have not taken any medication for dysmenorrhea like OC pills for last 3 months. 
 
ExclusionCriteria 
Details  1.Severe anemic patient with Hb less than 7 gm per dl
2.Abdominal pain associated with excessive bleeding PV, Endometriosis, PID, Fibroids, ovarian cyst like pelvic pathology.
3.Patients having any systemic illness i.e., known case of Hypertension, Diabetes Mellites, Hyperthyroidism, Hypothyroidism, Renal disorders, Hepatic disorders, sexually transmitted diseases, appendicitis.
4.Hysteric Patients.
5.Patient having congenital anomaly or structural anomaly.
6.Patient with Intrauterine contraceptive device.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1)Lower Abdominal pain
2)Lower backache
3)Headache
4)Nausea
5)Vomiting
6)Constipation
all above symptoms will be decreased. 		 First day of first menstrual cycle,first day of second menstrual cycle,first day of third menstrual cycle,first day of fourth menstrual cycle 
 
Secondary Outcome  
Outcome  TimePoints 
Above mentioned symptoms decreased.  First day of first menstrual cycle,first day of second menstrual cycle,first day of third menstrual cycle,first day of fourth menstrual cycle 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   30/01/2025 
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="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  

Dysmenorrhea is the most common gynecological problem faced by women during their adolescence resulting in physical discomfort and anxiety. In Ayurveda, Kashtartava is not described as a separate disease entity but there are many other diseases which can be correlated with Kashtartava like Vataja Yonivyapada, Udavarta Yonivyapada, Vataja Aartavadushti, etc.

According to modern science, Dysmenorrhea is painful menstruation of sufficient magnitude so as to incapacitate day-to-day- activities. The primary dysmenorrhea is the one where there is no identifiable pelvic pathology. The incidence of primary dysmenorrhea of sufficient magnitude pathology with incapacitation is about 15- 20%. Non-steroidal anti-inflammatory drugs (NSAID’s) are the main pharmacological treatments.

Dysmenorrhea is commonly reported menstrual disorder which affects the working ability and quality of life of women, which further affects community as well in terms of school and work absenteeism of females. Dysmenorrhea is a symptom complex with involvement of physical, psychological, emotional symptoms mainly affecting young females in the world, hampering their domestic, academic, social and professional pursuits.

The prevalence of a dysmenorrhea estimates ranges from 25-95% among women and adolescent.Prevalence of dysmenorrhea reported from the studies in India is 84.20% .

 PURPOSE OF SELECTION OF TOPIC-

          Most of the previous research works include treatment of Dysmenorrhea with  administration of Basti karma. Not all patients can invest required time, money and efforts for the procedure, so there is need to develop oral medication for the same. Use of NSAIDs for dysmenorrhea is more popular among younger age group as it provides faster relief and is easily available OTC,so there is need of time to develop Ayurvedic formulations which will be easy to administer, have no side effects and reduce the use of NSAIDs.

The Varshabhubilwadi Kashaya is Vata Kapha Prashamaka, Rakta Prasadaka, Vibandhagna, Vatanulomaka properties. It regulates Apana vayu so as to improve the functions of organs in Apan kshetra.

 

 
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