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CTRI Number  CTRI/2025/09/094337 [Registered on: 08/09/2025] Trial Registered Prospectively
Last Modified On: 04/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Oral medication for Dysmenorrhea patients for treating Pain in lower abdomen during Periods 
Scientific Title of Study   An Open Label Single Arm Clinical Study To Evaluate The Effect Of Streepriyadi Kwatha In Udavartini Yoni Vyapath 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  DR SHREEVALLI P 
Designation  PG SCHOLAR 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda Udupi 
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre Kuthpady Udupi-574118 Department of PG and P.H.D Studies in Prasootitantra Evam Streeroga.

Udupi
KARNATAKA
574118
India 
Phone  9113829315  
Fax    
Email  shreevallip02@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR SUCHETHAKUMARI 
Designation  HOD AND PROFESSOR 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda Udupi 
Address  SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA HOSPITAL AND RESEARCH CENTRE KUTHPADY UDUPI DEPARTMENT OF PG AND P.H.D STUDIES IN PRASUTITANTRA EVAM STREEROGA

Udupi
KARNATAKA
574118
India 
Phone  9448529574  
Fax    
Email  suchetha.sdm@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR SUCHETHAKUMARI 
Designation  HOD AND PROFESSOR 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda Udupi 
Address  SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA HOSPITAL AND RESEARCH CENTRE KUTHPADY UDUPI DEPARTMENT OF PG AND P.H.D STUDIES IN PRASUTITANTRA EVAM STREEROGA


KARNATAKA
574118
India 
Phone  9448529574  
Fax    
Email  suchetha.sdm@gmail.com  
 
Source of Monetary or Material Support  
Dr Shreevalli p PG Scholar Department of PG and PHD Studies in Prasootitantra evam Streeroga Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre Kuthpady Udupi 574118 
 
Primary Sponsor  
Name  Dr Shreevalli p 
Address  Srivari Nilaya Shankarapuram 4th cross B.H Road Tumakuru 572103 Karnataka 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
DR SUCHETHAKUMARI  SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA HOSPITAL AND RESEARCH CENTRE KUTHPADY UDUPI -574118 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR SHREEVALLI P  Sri Dharmasthala Manjunatheshwara Hospital  Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research centre Kuthpady Udupi Department of PG and PHD Studies in Prasutitantra Evam Streeroga
Udupi
KARNATAKA 
09113829315

shreevallip02@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL CLEARANCE COMMITTEE -HUMAN SDMCAU  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: STREEPRIYADI KWATHA, Reference: NA, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 10 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1 Spasmodic type of pain which is confined to lower abdomen or radiates to back and medial aspect of thighs.
2 Subjects with painful menstruation for atleast 2 consecutive cycles.
3 Known case of Secondary dysmenorrhea with underlying pelvic pathology uterine fibroids Adenomyosis endometriosis.
4 Patients of age between 18-40yrs
 
 
ExclusionCriteria 
Details  1 Subjects with hormonal therapies
2 Known case of congenital anamolies of reproductive system.
3 HB% is less than 6.5gm%.
4 Subjects with intrauterine contraceptive devices.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To Evaluate The Effect of Streepriyadi Kwatha In Udavartini Yoni Vyapath w.s.r to Dysmenorrhea  10 Days of 2 Consecutive Cycles
Follow Up On 5th Day Of Succesive 3rd Cycle 
 
Secondary Outcome  
Outcome  TimePoints 
Duaration of pain,site of pain,intensity of pain is together assessed by WaLIDD Scores.  10 Days For 2 Consecutive Cycles
Follow Up on 5th Day of Succesive 3rd Cycle 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   25/09/2025 
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="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Menstruation is a normal physiological process where every women undergo in their life time.During  menstruation there will be lot of physical and psychological changes.One such aspect is painful menstruation called as Dysmenorrhea which can be considered as Udavartini yoni vyapad.Udavartini is one among the twenty Yoni vyapath described by various Acharyas which is characterized by ‘Rajah krichrena munchathi’-discharge of menstrual blood with great difficulty, There will be immediate relief from pain following discharge of menstrual blood.The word dysmenorrhea is derived from greek origin and means difficult monthly flow but now it is taken to mean painful menstruation.Cyclic pain with menstruation is common and accompanies most menses(Weissman,2004).The pain is classically described as cramping and is often accompanied by low back ache,nausea andvomiting,headache or diarrhea. Prevalence of dysmenorrhoea world wide ranges 15.8-89.5% with a higher prevalence in adolescent girls.Prevalence of dysmenorrhea in adolescent girls are found to be 79.67%.Most of them 37.96% suffered regularly from dysmenorrhea severity.Dysmenorrhea incidence of 33.5% was reported by Nag (1982) among adolescent girls in India. A study done in Sweden showed that more than 50% of all menstruating women experience some discomfort. It has also been reported by a senior obstetrician that probably 5 – 10% of girls in their late teens suffer from severe spasmodic dysmenorrhea interrupting their educational and social life.Unlike primary dysmenorrhea,reports of secondary dysmenorrhea tend to increase with age,it is reported most often in women aged 30-45yrs.Since dysmenorrhea will be haunting women with their daily day to day activites and no such complete remedies are available in contemporary science.It is need of the hour to utilize Medicines told in Ayurveda and folklore which has so many magical remidies and timetested .

Streepriyadi kwatha is one such folklore formulation and Ashoka ,one of the ingredient of it is mentioned in ayurvedic classical text like charaka samhitha with its well known effective action in pain management.The practice of Ayurveda and folklore medicine has always went in hand by hand.In folklore practices there are so many effective remedies which are yet to be explored and need scientific authentication.The knowledge of folklore medicine is being a treasure.In this regard to mimimize the challenges faced during the painful menstruation,using the treasurable knowledge by Ayurveda and folklore sciences this study is taken up.



 
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