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CTRI Number  CTRI/2021/11/038045 [Registered on: 15/11/2021] Trial Registered Prospectively
Last Modified On: 12/11/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Ayurvedic drugs Soubhagyadi Gutika & Trivrit Taila Anuvasana Basti in the treatment of patients with pain during menstruation 
Scientific Title of Study   A comparative clinical study to evaluate the efficacy of Soubhagyadi Gutika & Trivrit Taila Anuvasana Basti in the management of Udavarta Yoni vyapad w.s.r. to Primary Dysmenorrhea  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anjali jain 
Designation  P.G. Scholar 
Affiliation  MADAN MOHAN MALVIYA GOVT. AYURVED COLLEGE UDAIPUR 
Address  P.G. Dept. of Prasuti tantra evam Stri Roga Madan Mohan Malviya Govt. Ayurved College, Radaji Circle Ambamata, Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  8440836606  
Fax    
Email  anjalijain1807@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Narendra Kumar Meena 
Designation  Associate Professor & Guide 
Affiliation  MADAN MOHAN MALVIYA GOVT. AYURVED COLLEGE UDAIPUR 
Address  PG Dept. of Prasuti tantra evam Stri Roga Madan Mohan Malviya Govt. Ayurved College Campus , Radaji Circle Ambamata, Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  09950129673  
Fax    
Email  narendermeena42@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Narendra Kumar Meena 
Designation  Associate Professor& Guide 
Affiliation  MADAN MOHAN MALVIYA GOVT. AYURVED COLLEGE UDAIPUR 
Address  P.G. Dept. of Prasuti tantra evam Stri Roga Madan Mohan Malviya Govt. Ayurved College, Radaji Circle Ambamata, Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  09950129673  
Fax    
Email  narendermeena42@yahoo.com  
 
Source of Monetary or Material Support  
Madan Mohan Malviya Govt. Ayurved College udaipur 
 
Primary Sponsor  
Name  Madan Mohan Malviya Govt Ayurved College Udaipur 
Address  Madan Mohan Malviya Govt. Ayurved College, Radaji Circle Ambamata, Udaipur 313001 
Type of Sponsor  Government 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 Narendra Kumar Meena  Madan Mohan Malviya Govt. Ayurved College, Udaipur  OPD Room no. 5, P.G. Dept. of Prasuti tantra evam Stri Roga Madan Mohan Malviya Govt. Ayurved College, Radaji Circle Ambamata, Udaipur
Udaipur
RAJASTHAN 		 9950129673

narendermeena42@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Madan Mohan Malviya Govt. Ayurved College, Udaipur  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: उदावर्ता योनि व्यापद ,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Soubhagyadi Gutika, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: luke warm water), Additional Information:
2Comparator ArmProcedure-anuvAsana-bastiH, अनुवासन-बस्तिः (Procedure Reference: Ashtanga Sangraha Uttar sthan 39/42, Procedure details: 25-50ml / day for 7 alternate days started 14 days before onset of menstrual cycle for 3 consecutive menstrual cycle. )
(1) Medicine Name: Soubhagyadi gutika , Reference: Ras Tantra Sara evam Siddha Yoga Sangraha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: bd, Duration: 90 Days
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Patient Suffering from Dysmenorrhoea and willing for trial.
2. Patient with chief complaint of painful menstruation with scanty or average amount of menses.
3. The patient who ages in between 16-40 years will be selected.
 
 
ExclusionCriteria 
Details  1. Patient below the age of 16 and above 40 years.
2. Patient suffering from chronic illness.
3. Patient having any uterine pathology e.g. endometriosis, adenomyosis, fibroid uterus etc.( secondary dysmenorrhea)
4. Patient having pain in abdomen associated with menorrhagia and metrorrhagia.
5. Women using intrauterine contraceptive devices
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
improvement in sign & symptoms of patients from the treatment  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
efficacy of treatment  3 months 
 
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)   23/11/2021 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   this study is to evaluate the efficacy of Soubhagyadi Gutika & Trivrit tail Anuvasana Basti in the treatment of Udavarta Yoni Vyapad w.s.r. to Primary Dysmenorrhea.  The study will be conducted in 2 groups. In group A, 15 patients of Udavarta Yoni Vyapad will be treated by oral Soubhagyadi Gutika of the dose 250mg twice a day with lukewarm water for 90 days. In group B 15 patients of Udavarta Yoni Vyapad will be treated by oral Soubhagyadi Gutika & Trivrit tail Anuvasana Basti ( Matra Basti)  of the dose 250mg twice a day with lukewarm water for 90 days  & 25-50 ml/ days for 7 alternate days started 14 days before the onset of menstruation cycle for 3 consecutive menstrual cycles. 
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