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CTRI Number  CTRI/2021/02/030961 [Registered on: 03/02/2021] Trial Registered Prospectively
Last Modified On: 24/01/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effect of Pradarahara Kasaya And Pathyamalakyadi Kasaya In Excessive Menstrual Bleeding 
Scientific Title of Study   An Open Labelled Randomised Comparative Clinical Study On The Effect Of Pradarahara Kasaya And Pathyamalakyadi Kasaya In The Management Of Asrigdara W.S.R To Dysfunctional Uterine Bleeding 
Trial Acronym  Asrigdara (D.U.B) 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shobha Yadav 
Designation  PG Scholar 
Affiliation  Parul University 
Address  Room no 308 Department Of Prasuti Tantra Evum Stree Roga Parul Institute Of Ayurveda Parul University P O Limda Tal Waghodia Vadodara GUJARAT 391760 India

Vadodara
GUJARAT
391760
India 
Phone  8954493104  
Fax  02668-260201  
Email  drshobhavy09@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rita B Makim 
Designation  Professor 
Affiliation  Parul University 
Address  Room no 308 Department Of Prasuti Tantra Evum Stree Roga Parul Institute Of Ayurveda Parul University P O Limda Tal Waghodia Vadodara GUJARAT 391760 India

Vadodara
GUJARAT
391760
India 
Phone  7990727524  
Fax  02668-260201  
Email  ritamakim@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rita B Makim 
Designation  Professor 
Affiliation  Parul University 
Address  Room no 308 Department Of Prasuti Tantra Evum Stree Roga Parul Institute Of Ayurveda Parul University P O Limda Tal Waghodia Vadodara GUJARAT 391760 India

Vadodara
GUJARAT
391760
India 
Phone  7990727524  
Fax  02668-260201  
Email  ritamakim@gmail.com  
 
Source of Monetary or Material Support  
Parul Ayurved Hospital, Parul University, Vadodara,391760 
 
Primary Sponsor  
Name  Parul Institute Of Ayurved 
Address  Room no 308 Department Of Prasuti Tantra Evum Stree Roga Parul Institute Of Ayurveda Parul University PO Limda Tal Waghodia Vadodara GUJARAT 391760 India 
Type of Sponsor  Research institution and hospital 
 
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 Rita Makim  Parul Ayurved Hospital  Room no 308 Department Of Prasuti Tantra Evum Stree Roga Parul Institute Of Ayurveda Parul University P O Limda Tal Waghodia Vadodara GUJARAT 391760 India
Vadodara
GUJARAT 		 7990727524
02668-260201
ritamakim@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee For Human Research  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: ASRUGDARAH/RAKTAPRADARAH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Pathyamalakyadi Kasaya  48 ml BD for 60 days 
Intervention  Pradarahara Kasaya  48 ml BD for 60 days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Patients fulfilling the diagnostic criteria
Patients diagnosed as DUB
Both married and unmarried women
Patients ready to sign the informed consent form 
 
ExclusionCriteria 
Details  Patients with systemic disorders
Patients with IUCD and patients taking OCPs
Patients with uterine and pelvic pathology
Benign and malignant growth in uterus
Endometrial and endocervical polyp
Threatened, spontaneous or incomplete abortion
Patients having Hb % less than 8 grams 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Beneficial for irregular, prolonged and heavy menses  35 days 
 
Secondary Outcome  
Outcome  TimePoints 
Also reduce symptoms like angamarda, daurbalya, bhrama, aruchi, daha, trusha etc  15 days 
 
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   Phase 2 
Date of First Enrollment (India)   10/02/2021 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Will be done after completion of trial 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The process of cyclic menstruation is natural phenomenon. Regular cyclic menstruation results from the relationship between the endometrium and its regulating factors. Menstruation denotes the healthy state of female reproductive system but if the cycle turns to be abnormal with excessive and prolonged bleeding, associated with pain or during intermenstrual period, it is suggestive of some underlying pathology. In modern science asrigdara can be closely co-related with DUB. Dysfunctional uterine bleeding is best defined as abnormal uterine bleeding without any clinically detectable organic, systemic and iatrogenic cause (pelvic pathology i.e tumors, inflammation or pregnancy is excluded). The current line of treatment include medical and surgical methods, plays insignificant role besides the adverse effects. Hormones play a major role in the management of DUB (Asrigdara) but their use for longer period is proved to be dangerous and sometimes induce carcinogenic effect on the genital tract. In view of the problems of the current therapies, need is felt to revalidate certain ayurvedic formulations for the management of asrigdara without adverse effects. 
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