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CTRI Number  CTRI/2020/07/026517 [Registered on: 13/07/2020] Trial Registered Prospectively
Last Modified On: 08/10/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study The effect of DARVYADIGHANVATI IN exessive per vaginal bleeding during menstrual cycle in PUBERTY . 
Scientific Title of Study   Randomized Open Controlled Clinical Study To Evaluate Efficacy Of Darvyadighanvati In Asrugdara W.S.R.To Puberty Menorrhagia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrKavita Chandrashekhar Mule 
Designation  Associate Professor 
Affiliation  Yashwant Ayurved college PGT and RC Kodoli 
Address  Yashawant Ayurved college PGT and RC Kodoli TA Panhala Dist Kolhapur Strirog and Prasuti tantara department OPD ground floor room number 8
CSMSSs Ayurved Mahavidyalaya Kanchanvadi Aurangabad Strirog And Prasuti Tantra Department OPD ground floor room number 3
Kolhapur
MAHARASHTRA
416114
India 
Phone  9423277612  
Fax    
Email  kvt126@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jayashri S Deshmukh  
Designation  Professor and HOD 
Affiliation  MUHS Nashik 
Address  CSMSSs Ayurved Mahavidyalaya Kanchanvadi Aurangabad Prasuti tantra And Strirog Deparment !st floor
CSMSSs Ayurved Mahavidyalaya Kanchanvadi Aurangabad Prasuti tantra And Strirog Deparment OPD ground floor room no 3
Aurangabad
MAHARASHTRA
431002
India 
Phone  9325580777  
Fax    
Email  dr.jayashrisdeshmukh@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrKavita Chandrashekhar Mule 
Designation  Associate Professor 
Affiliation  yashwant Ayurved college PGT and RC Kodoli 
Address  Yashawant Ayurved college PGT and RC Kodoli TA Panhala Dist Kolhapur PrasutiTantra And Streerog Deparment OPD ground floor room no 8
CSMSSs Ayurved Mahavidyalaya Kanchanvadi Aurangabad PrasutiTantra And Streerog Deparment OPD ground floor no 3
Kolhapur
MAHARASHTRA
416114
India 
Phone  9423277612  
Fax    
Email  kvt126@gmail.com  
 
Source of Monetary or Material Support  
Dr Kavita Chandrashekhar Mule Associet Professor Yashawant Ayurved college PGT and RC Kodoli TA Panhala Dist Kolhapur PrasutiTantra And Streerog Deparment OPD ground floor no 8  
 
Primary Sponsor  
Name  DrKavita chandrashekhar mule 
Address  F8 modern plaza kibile gali kodoli ta panalha dist kolhapur  
Type of Sponsor  Other [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 Kavita Chandrashekhar Mule  Yashwant Ayurved college and Hospital kodoli  Yashwant Ayurved college and Hospital kodoli Strirog and Prasuti tantra Deparment OPD ground floor room number 8
Kolhapur
MAHARASHTRA 		 9423277612

kvt126@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CSMSSs Ayurved Mahavidyalay Kanchanvadi Aurangabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E308||Other disorders of puberty,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Darvyadighanvati   Darvyadighanvati 500mg BD after meal for three months 
Comparator Agent  Norethesteron  Norethesteron 0.5mg TID for 7days followed by BD for 7 days followed by OD 7days .  
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  19.00 Year(s)
Gender  Female 
Details  Age 13 yrs to 19 years
Patients with prolonged cycles,
excessive bleeding p/v during menstruation, more than three pads
Dysfunctional Uterine Bleeding
Hb% 8 grams% and above
 
 
ExclusionCriteria 
Details  H/o Endocrinal disorders
H/o Bleeding dyscrasias
Intermenstrual bleeding
H/o Structural abnormality in genital organs
H/o Any other systemic illness
H/o Genital tuberculosis
PCOD
Hb% < 8gm%
H/o Juvenile Diabetes Mellitus
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
minimize exessive bloodloss in Asrugdhara (Puberty menorragia)   15 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
TO Minimize Excessive Blood Loss . An Alternative Hormonal Therapy In Puberty Menorrhagia  whiten three month of period  
 
Target Sample Size   Total Sample Size="125"
Sample Size from India="125" 
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 
Date of First Enrollment (India)   16/07/2020 
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="6"
Days="10" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  		 I DR. Kavita Chandrashekhar Mule Associete  Professor PrasutiTantra & Streerog Department  at YashwantAyurved College Kodoli And Registered for In service ( teacher quota) PhD Scolar At CSMSSs Ayurved Mahavidyalay Kanchanwwadi  Aurangabad  under Maharashra Univercity Of Health Sciences  Nashik.
This  Present Study is related to menstrual Problem like Ashrugdara  W>S>R>to Puberty Menorrhagia which is common gynecological   disorder that may land towards morbidity ,anemia in adolescence girls  They may stay away from schools and social functions due to inconvinance caused by excessive flow and fatigue Puberty age is step towards motherhood.
In trial drug Darvyadighanvati  an non hormonal Ayurvedic drug  will be given in Puberty menorrhagia  .
Government of India runs National Program for Child and Mother in  which identify and treatment  for  anemia  in adolescence girlis done. In puberty age anemia is mainly due to menorrhagia ,so this topic helpful to Government of India as Puberty Menorrhagia is treated with Darvyadighanvati non hormonal Ayurvedic drug.
 
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