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CTRI Number  CTRI/2025/06/089243 [Registered on: 20/06/2025] Trial Registered Prospectively
Last Modified On: 12/06/2025
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   How effective kulatthadi Kashay is will be checked in dysmenorrhea patients 
Scientific Title of Study   Randomized controlled clinical study to evaluate the efficacy of kulatthadi kashay in 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 Sameeksha Chandrashekhar Charpe 
Designation  PG Scholar 
Affiliation  C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad India 431001 
Address  OPD No 19 Prasuti Tantra and Streeroga Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 Aurangabad MAHARASHTRA 431011 India

Aurangabad
MAHARASHTRA
431011
India 
Phone  7709558572  
Fax    
Email  charpes98@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sandhya M Yennawar 
Designation  Associate Professor  
Affiliation  C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad India 431001 
Address  OPD No 19 Prasuti Tantra and Streeroga Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 Aurangabad MAHARASHTRA 431011 India

Aurangabad
MAHARASHTRA
431011
India 
Phone  9850562524  
Fax    
Email  dryennawar11@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sameeksha Chandrashekhar Charpe 
Designation  PG Scholar  
Affiliation  C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad India 431001 
Address  OPD No 19 Prasuti Tantra and Streeroga Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 Aurangabad MAHARASHTRA 431011 India

Aurangabad
MAHARASHTRA
431011
India 
Phone  7709558572  
Fax    
Email  charpes98@gmail.com  
 
Source of Monetary or Material Support  
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad India 431001 
 
Primary Sponsor  
Name  C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad India 431001 
Address  C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad India 431001 
Type of Sponsor  Private medical college 
 
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 Sameeksha Chandrashekhar Charpe  C.S.M.S.S Ayurved Mahavidyalaya, Aurangabad  OPD No 19 Prasuti Tantra and Streeroga Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 Aurangabad MAHARASHTRA 431011 India
Aurangabad
MAHARASHTRA 		 7709558572

charpes98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CSMSS Ayurved Mahavidyalaya Aurangabad   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 ArmDrugOther than Classical(1) Medicine Name: Shatapushpa Churna , Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 20 Days, anupAna/sahapAna: Yes(details: -Koshna Jal), Additional Information: -Duration of Treatment - 7 days prior and 3 days of menstruation in each cycle Follow up -2
2Intervention ArmDrugClassical(1) Medicine Name: Kulatthadi Kashay , Reference: Sahasrayog ( Shlok No-91), Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 20 Days, anupAna/sahapAna: No, Additional Information: -Duration of Treatment - 7 days prior and 3 days of menstruation in each cycle Follow up - 2
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  24.00 Year(s)
Gender  Female 
Details  1. Diagnosed patients of Udavartini Yonivyapad of age group from 10 to 24 years young unmarried patient.
2. Patient having chief complaints of painful menstruation with associated symptoms without any pelvic pathology. 
 
ExclusionCriteria 
Details  1. Patients of age group below 10 & above 24 years married patients.
2. Patients of pelvic pathology i.e. PID, PCOD, Cervical stenosis, Fibroid, Endometriosis, DUB, Adenomyosis, Endometrial polyp.
3. Patient taking any hormonal therapy.
4. Patient with congenital anomalies of reproductive system.
5. Menorrhagia 
 
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 
Lakshanas of Udavartini Yonivyapad will decrease  Baseline-30th, 60th day 
 
Secondary Outcome  
Outcome  TimePoints 
1.Study Udavartini yonivyapad according to
Ayurveda.
2.Study Primary Dysmenorrhea according to
Modern.
3.Compare the effect of Kulatthadi
Kashay and Shatapushpa churna in the
management of Udavartini Yonivyapad. 		 Baseline-30th, 60th day 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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/ Phase 3 
Date of First Enrollment (India)   28/06/2025 
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                  In Ayurvedic classics Gynaecological disorders have been described  under caption Yonivyapad. Among them Udavartini Yonivypad given by  Acharya Charak is closely related to the symptoms of Primary Dysmenorrhea. Here Vata vitiated by vegadharana pushes the menstrual blood upward and then expel it out with difficulty leading to pain. Pain will relieve by itself once the menstrual flow starts, which itself indicate the spasmodic nature of pain. Acharya Sushrut said such symptoms in Udavarta Yonivyapad, the women eliminates frothy menstrual blood with difficulty. Acharya Vagbhat also mentioned Vata aggravated by suppression of the urges, torments the vagina and expels frothy menstrual blood with difficulty.  All classical Samhitas like Charak Samhita, Sushrut Samhita, Vagbhat Samhita have mentioned Udavartini/Udavarta/ Udavritta Yonivyapad respectively as Vataj Yonivyapad. So Vatanulomak and Vatashamak dravyas have main role in treatment. Kulatthadi Kashay is one among lots of herbal preparation which has indication in Udavarta and shul.
             Prevalence of Dysmenorrhea in India is 70.2%. Majority of subjects experienced pain for 1-2 days during menstruation. 23.2% girls experienced pain for 2-3 days during menstruation. It is responsible for highest incidence of absenteeism resulting in loss of work hours and economic loss. Hence these females are forced to take antispasmodic, analgesics, prostaglandin synthetase inhibitors etc. during menstruation. However Prostaglandin synthetase inhibitors are contraindicated in women with gastrointestinal ulcer and bronchial asthma. Side effects includes nausea, vomiting, blurred vision,
nephrotoxicity and gastric ulcer on prolong use.
             Previous studies on Udavartini Yonivyapad primarily focused on various types of Basti, and there are very few studies on oral medication. This reveals the necessity of alternate treatment to tackle this situation with suitable remedies. Kulatthadi Kashay mentioned in Sahasrayoga containing drugs which are Kulattha, Lahsun, Erand, Patha, Granthik, Nagar and Yavkshar having properties of Dipan, Pachan, Anuloman and Vedanashaman. Previously no research was done on Kulatthadi Kashay, considering above facts it is selected for study.
             Study will be conducted on 100 diagnosed patients of Udavartini Yonivyapad. Written consent will be taken. Initial assessment will be done. Patient treated with interventional group Kulatthadi Kashay and control group Shatapushpa Churna. Patients will be assessed at follow ups. Observation and Results will be noted and Statistical Analysis, Discussion and Conclusion will be drawn.
 
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