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CTRI Number  CTRI/2021/02/031560 [Registered on: 25/02/2021] Trial Registered Prospectively
Last Modified On: 11/02/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   An open label single arm clinical trial to evaluate the effect of Naarikela pushpaadi kashaya in Asrugdara (Dysfunctional Uterine Bleeding) 
Scientific Title of Study   A clinical study to evaluate the EFFECT OF NAARIKELA PUSHPAADI KASHAYA IN ASRUGDARA (DYSFUNCTIONAL UTERINE BLEEDING) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Reshma E 
Designation  Pg scholar  
Affiliation  SDM college of Ayurveda Hassan  
Address  SDM college of Ayurveda and hospital BM road thannirhalla Hassan Karnataka
SDM college of Ayurveda Hassan
Hassan
KARNATAKA
573201
India 
Phone  9400510383  
Fax    
Email  drreshmaayu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Madhu M 
Designation  Associate professor  
Affiliation  SDM college Of Ayurveda And Hospital Hassan 
Address  Dptmnt of Prasuti Tantra and stri roga SDM college Of Ayurveda Hassan Karnataka
SDM college of Ayurveda and hospital Hassan BM road thannirhalla Karnataka
Hassan
KARNATAKA
573201
India 
Phone  8970167939  
Fax    
Email  drmadhu.ayu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Madhu M 
Designation  Associate professor  
Affiliation  SDM college Of Ayurveda And Hospital Hassan 
Address  Dptmnt of Prasuti Tantra and stri roga SDM college Of Ayurveda Hassan Karnataka
SDM college of Ayurveda and hospital Hassan BM road thannirhalla Karnataka
Hassan
KARNATAKA
573201
India 
Phone  8970167939  
Fax    
Email  drmadhu.ayu@gmail.com  
 
Source of Monetary or Material Support  
SDM college of Ayurveda  
 
Primary Sponsor  
Name  SDM college of Ayurveda and hospital Hassan 
Address  SDM college of Ayurveda Hassan 
Type of Sponsor  Private 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 Reshma   SDM college of Ayurveda And Hospital,BM road, thanniruhalla, Hassan  Out patient and inpatient department of Prasutitantra and striroga (Ayurvedic Obs &Gyn) opd number 20
Hassan
KARNATAKA 		 9400510383

drreshmaayu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (2) ICD-10 Condition: N920||Excessive and frequent menstruation with regular cycle, (3) ICD-10 Condition:N920||Excessive and frequent menstruation with regular cycle. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparator nil  Comparator nil 
Intervention  Naarikela pushpaadi kashayam (thenginpookkuladi kashayam)  Dose -25 ml kashaya +25 ml like warm water mixed together.Twice daily 1 hour before food Route of Administration -oral Duration-2 months intervention + 1 month follow up Ingredients are Naarikela pushpa -inflorescence of coconut tree Japa moola -root of hibiscus Bala moola- root of sida retusa Jambuvalkala-bark of siyzygium cumini 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Subject with menstral bleeding for more than 5 days in each cycle
Patient using more than 3 completely soaked pads per day
Intermenstrual bleeding
Subjects with signs and symptoms of Asrugdara for at least 3 months
 
 
ExclusionCriteria 
Details  Known case of threatened or incomplete abortion
Known case of coagulation and bleeding disorders
Known case of thyroid dysfunction
Known case of sexually transmitted diseases
Using intra Uterine and oral contraceptives
Known case of benign and malignant growth in uterus  
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Assessment of symptoms such as excessive bleeding,prolonged bleeding,intermenstural bleeding,clotsAfter 2 months intervention (8 weeks)
Assessment will be done. 		 After 2 months intervention-1 month follow up  
 
Secondary Outcome  
Outcome  TimePoints 
Attainment of Regular menstruation   3months 
 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/03/2021 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Other (Terminated) 
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)?  

Response - NO
Brief Summary   It is an open label single arm clinical trial to evaluate the effect of Naarikela pushpaadi kashaya in Asrugdara ( Dysfunctional Uterine Bleeding).A minimum of 30 patients who are fulfilling the diagnostic and inclusion criteria will be selected from outpatient and inpatient department of prasuti tantra and striroga  SDM college of Ayurveda and hospital Hassan.A screening form will be prepared with all aspects of history, signs and symptoms of Asrugdara and laboratory investigations to rule out major illnesses.During this process patients will be thoroughly screened for signs and symptoms of Asrugdara.Naarikela pushpaadi kashaya which is mentioned in sahasrayogam in the name of Thenginpookkuladi kashaya will be administered in the dose of 25 ml twice daily ,half an hour before food diluted with equal quantity of lukewarm water for two consecutive menstrual cycles.Required drugs will be collected from south India and authenticate after taxonomical identification and will be prepared in the teaching pharmacy of SDM college of Ayurveda and hospital. 
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