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CTRI Number  CTRI/2023/10/058399 [Registered on: 06/10/2023] Trial Registered Prospectively
Last Modified On: 05/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Clinical Trial on Ayurvedic Tablet Kanyalohadi Vati foR Primary Dysmenorrhea 
Scientific Title of Study   EVALUATION OF EFFICACY OF KANYALOHADI VATI IN UDAVARTINI YONIVYAPATH VIS A VIS TO PRIMARY DYSMENORRHOEA -AN OPEN LABEL SINGLE ARM CLINICAL STUDY  
Trial Acronym  no 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sonal Singh 
Designation  PG Scholar 
Affiliation  JSS Ayurveda Medical College 
Address  Department of PG studies in Prasooti Tantra and Stree Roga, JSS AyurvAedic Medcal College and Hospital Llithadripura road MYSORE

Mysore
KARNATAKA
570028
India 
Phone  9634747023  
Fax    
Email  singh.sonal80808@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Semantini Dundappa Yalagudri 
Designation  Peofessor 
Affiliation  JSS Ayurveda Medical College 
Address  Department of PG studies in Prasooti Tantra and Stree Roga, JSS AyurvAedic Medcal College and Hospital Llithadripura road MYSORE

Mysore
KARNATAKA
570028
India 
Phone  7349496230  
Fax    
Email  seemantinij@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Sonal Singh 
Designation  PG Scholar 
Affiliation  JSS Ayurveda Medical College 
Address  Department of PG studies in Prasooti Tantra and Stree Roga, JSS AyurvAedic Medcal College and Hospital Llithadripura road MYSORE

Mysore
KARNATAKA
570028
India 
Phone  9634747023  
Fax    
Email  singh.sonal80808@gmail.com  
 
Source of Monetary or Material Support  
JSS Ayurveda Medical College and Hospital 
 
Primary Sponsor  
Name  Dr Sonal Singh 
Address  Department of PG studies in Prasooti Tantra and Stree Roga, JSS AyurvAedic Medcal College and Hospital Llithadripura road MYSORE 
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 Sonal Singh  JSS ayurveda medical college  The Drug Required For The Study Will Be Procured From GMP cerified pharmacy and the Study Will Be Conducted In OPD no.9 and IPD of Department of Prasooti Tantra and Stree Roga at JSS Ayurveda Medical College And Hospital College And Hospital.
Mysore
KARNATAKA 		 9634747023

singh.sonal80808@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JSS Ayurveda Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N00-N99||Diseases of the genitourinary system. Ayurveda Condition: UDAVARTINI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: kanyalohadi vati , Reference: rastantra and sara sangraha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -warm water), Additional Information: -the medicine contains all the ingredient which have a property of vatahara, vataanuloma and vedanasthapana dravyas
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  32.00 Year(s)
Gender  Female 
Details  -Age group 16-32 years
-patient with regular cycles complaining of painful menstruation for at least three consecutive cycles
 
 
ExclusionCriteria 
Details  -Pelvic pathology – Known case of Fibroid, Adenomyosis, Endometriosis, PID, Menorrhagia, Malignancy.
-Patients with intrauterine contraceptive devices or on contraceptive pills.
-Congenital anomalies of reproductive system.
-Metabolic disorders – known case of Diabeties Mellitus , Hypertension , Thyroid dysfunction.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
this study is done for symptomatic management of pain in primary dysmenorrhea with ayurvedic tablet kanyalohadi vati  30 Days 
 
Secondary Outcome  
Outcome  TimePoints 
this medicine will help to get rid of painful menses experience , & will not lead to effect the day to day activity  90 days 
Symptomatic Relief In The Symptoms  90 Days 
 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   20/10/2023 
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="5"
Days="30" 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ singh.sonal80808@gmail.com].

  6. For how long will this data be available start date provided 22-01-2025 and end date provided 22-01-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

•      As  per Ayurveda  predominant factor for dysmenorrhoea  is Vata.  Apanavata  is  the  governing force  of  menstruation.  Its  vitiation  gives  rise  to   diseases under the entity of   yonivyapada’s Udavartini is  one  among them, where   vitiated Vata  moves  in  pratiloma gati leading to ‘painful menstruation’.  The  treatment   indicated is  normalization  of Vata.[1]

•        As dysmenorrhoea  is  one  of  the  most  common complaints amongst adolescents, it affects the quality of life  of  many  women  in  their  reproductive  age , Because  of  sedentary  life  style and  food  habits  this  problem  is increasing  day  by  day worldwide.  About 25-50%  of  adult  women  and  about  75%  of  adolescents experience  pain  during  menstruation,  with  5  -20% reporting  severe  dysmenorrhea  [2]. Dysmenorrhoea can also be associated with nausea, vomiting, diarrhea, fatigue,  which  disturbs  routine  activities . Dysmenorrhoea   is   the  leading  cause of short term school  absenteeism.  It  is associated  with  a  negative impact on social, academic and sports activities of many female adolescent [3].

•      As in cases of udavartini yoni vyapatha, vataprakopa is the main cause, the treatment should be directed to treat the vitiated  vata and to eradicate  the cause ,hence an attempt is made to treat with vatahara, vataanuloma and vedanasthapana dravyas .

As the drug which is used is palatable, cost effective and can be taken easily with busy schedule and will impact effective cure without any inconvenience . 
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