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CTRI Number  CTRI/2022/10/046596 [Registered on: 18/10/2022] Trial Registered Prospectively
Last Modified On: 04/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Compare The Effect Of Kutajashtak Churna And Samangadi Kwath On Heavy Periods 
Scientific Title of Study   A Comparative Clinical Study Of Kutajashtak Churna And Samangadi Kwath On Asrigdara W.S.R. To Menometrorrhagia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sonu Kumari 
Designation  PG Scholar 
Affiliation  Madan Mohan Malviya Govt Ayurved college 
Address  PG Department Of Prasuti Tantra Evam Stri Roga Madan Mohan Malviya Govt Ayurved college Ambamata

Udaipur
RAJASTHAN
313001
India 
Phone  7597424752  
Fax    
Email  dr.sonumanojrolan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Mahesh Dixit 
Designation  Principal & Guide 
Affiliation  Madan Mohan Malviya Govt Ayurved college 
Address  PG Department Of Prasuti Tantra Evam Stri Roga Madan Mohan Malviya Govt Ayurved college Ambamata

Udaipur
RAJASTHAN
313001
India 
Phone  9414245459  
Fax    
Email  prof.maheshdixit@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Mahesh Dixit 
Designation  Principal & Guide 
Affiliation  Madan Mohan Malviya Govt Ayurved college 
Address  PG Department Of Prasuti Tantra Evam Stri Roga Madan Mohan Malviya Govt Ayurved college Ambamata


RAJASTHAN
313001
India 
Phone  9414245459  
Fax    
Email  prof.maheshdixit@gmail.com  
 
Source of Monetary or Material Support  
Madan Mohan Malviya Govt Ayurved college 
 
Primary Sponsor  
Name  Madan Mohan Malviya Govt Ayurved college 
Address  Madan Mohan Malviya Govt Ayurved college Ambamata Udaipur 
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 
Prof Mahesh Dixit  Madan Mohan Malviya Govt Ayurved college  OPD room no.5 PG Department Of Prasuti Tantra Evam Stri Roga
Udaipur
RAJASTHAN 		 9414245459

prof.maheshdixit@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N921||Excessive and frequent menstruation with irregular cycle. Ayurveda Condition: patients with heavy irregular periods, (2) ICD-10 Condition:N921||Excessive and frequent menstruation with irregular cycle. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Kutajashtak churna, Reference: Yogratnakar pradara rodhini chikitsa 18, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Ghrita and Sharkara), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: samangadi kwath, Reference: harita samhita tritiya stan 10/82, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -comparator arm will be given kutajashtak churna and samangadi kwath
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1 patients willing for the trial
2 patients between the age group of 18-45 years
3 patients with either one or all symptoms of Asrigdara like Ritu Atipravritti (excessive bleeding during menstruation) Deergha Pravritti (prolonged bleeding) 
 
ExclusionCriteria 
Details  1 patients before 18 years and after 45 years of age
2 patients with uterine and pelvic pathology like big fibroid carcinoma cervix cervical polyp endometrial carcinoma chronic medical illness etc
3 bleeding due to coagulation disorders
4 patients had bleeding due to abortions 
 
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 the sign & symptoms from the treatment in the patients  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
efficacy of treatment  3 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   15/11/2022 
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 about comparing the effect of kutajashtak churna and samangadi kwath in the management of asrigdara w.s.r. to Menometrorrhagia . there will be two groups of 20-20 patients in which group A patients will be treated with kutajashtak churna 5gm orally BD with ghrita and sharkara . group B patients will be treated with  kutajashtak churna (5gm) with samangadi kwath (40ml) orally BD for three consecutive menstrual cycles. 
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