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CTRI Number  CTRI/2020/11/028989 [Registered on: 09/11/2020] Trial Registered Prospectively
Last Modified On: 06/11/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Curative ]  
Study Design  Other 
Public Title of Study   Kashmari phal in excessive bleeding during menstruation  
Scientific Title of Study   A CLINICAL STUDY TO EVALUATE THE EFFICACY OF KASHMARI PHAL IN ASRIGDARA 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vaishali Dave  
Designation  Assistant Professor  
Affiliation  J S Ayurveda Mahavidyalay  
Address  Department of Prasutitantra ans striroga , JS Ayurveda Mahavidyalay, College Road, Nadiad
Sai Smruti 188/1 Sector 2B Opp. Infocity 382007
Gandhinagar
GUJARAT
387001
India 
Phone  9662140078  
Fax    
Email  vaishalivasavda@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vaishali Dave  
Designation  Associate Professor  
Affiliation  J S Ayurveda Mahavidyalay  
Address  Room no 205, Department of Prasutitantra evam Strirog JS Ayurveda Mahavidyalay, College Road, Nadiad
Sai Smruti 188/1 Sector 2B Opp. Infocity 382007
Gandhinagar
GUJARAT
387001
India 
Phone  9662140078  
Fax    
Email  vaishalivasavda@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vaishali Dave  
Designation  Assistant Professor  
Affiliation  J S Ayurveda Mahavidyalay  
Address  Room no 205, Department of Prasutitantra evam Striroga , JS Ayurveda Mahavidyalay, College Road, Nadiad
Sai Smruti 188/1 Sector 2B Opp. Infocity 382007
Gandhinagar
GUJARAT
387001
India 
Phone  9662140078  
Fax    
Email  vaishalivasavda@gmail.com  
 
Source of Monetary or Material Support  
JS Ayurveda Mahavidyalaya, Nadiad  
 
Primary Sponsor  
Name  DrVaishali Dave 
Address  A/8 Lalbaug Society Opp. Umabhavan, Amroli Surat Gujarat India 394107 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
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 
DrVaishali Dave  JS Ayurved Mahavidyalay   Room no 205, Department of Prasutitantra evam striroga J S Ayurveda Mahavidyalaya College Road Nadiad
Kheda
GUJARAT 
9662140078

vaishalivasavda@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ICEHR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N920||Excessive and frequent menstruation with regular cycle. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kashmari phal   Kashmari phal 5gm Orally with warm water twice a day for 2 months. 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Age 13- 45 years. and willing to give their consent to participate in the study.
Patients with pratyatma lakshanas of asrigdara.
Patients diagnosed as DUB 
 
ExclusionCriteria 
Details 
Patients with chronic illness.
Patients using intrauterine contraceptive device.
Patients with uterine and Pelvic pathology.
Benign and malignant growth.
Threatened , spontaneous or incomplete/ Ectopic pregnancy 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Kashmari phal will be effective in controlling excessive bleeding during menstruation   4 week , then 8th week after treatment  
 
Secondary Outcome  
Outcome  TimePoints 
Reoccurrence of Condition will be prevented   after 2 months 
 
Target Sample Size   Total Sample Size="5"
Sample Size from India="5" 
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)   14/11/2020 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nill 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Rhythm and periodicity are the characteristics of a woman’s life, so is her menstruation. Every healthy woman menstruates regularly and rhythmically every month during her reproductive age. Any change in this normal rhythm brings curious concern to women. Dysfunctional uterine bleeding(DUB) is excessive abnormal uterine bleeding for which organic causes or pelvic pathology cannot be found.1 As we see symptoms of Asrigdara it appears analogues to DUB.

The WHO reports that 18 million women in the reproductive period suffers from DUB. Excessive menstrual bleeding is a significant cause of morbidity during the reproductive years.2Dysfunctional Uterine Bleeding has a wide spectrum of presentations that range from heavy uterine bleeding that warrant hospital admission and emergency treatment to occasional irregular uterine spotting anytime throughout the cycle. The treatment options in these conditions by modern medicines often require a combination of invasive surgical procedures. Taking into account the side effects and adverse effects, The Ayurvedic management can be recommended as a safer, feasible and effective therapy for the management of heavy menstrual bleeding. The first line of treatment for Asrukdar is Raktapittanashana Chikitsa.3Acharya charaka mentioned kashmariphala as best Raktapitta hara and Rakta sangrahaka4. Compare to other medication kashmari phal is easily available and cost effective. Hence Kashmari is selected as a trial drug to cure Asrukdar.

 
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