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CTRI Number  CTRI/2025/02/080149 [Registered on: 07/02/2025] Trial Registered Prospectively
Last Modified On: 04/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Comparative Clinical Study to understand the effectiveness of internal administration of Vasadi Dravya Kashaya, Sarasijamakarandadi choorna, Virechana Karma in the management of Heavy Menstrual Bleeding 
Scientific Title of Study   Effectiveness of Vasadi Dravya Kashaya, Sarasijamakarandadi Choorna, Virechana in the management of Asrgdara- A Comparative Clinical Study  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anagha S 
Designation  Part time PhD Scholar  
Affiliation  SDM College of Ayurveda 
Address  Department of Prasuti Tantra and Stree Roga SDM College of Ayurveda Kuthpady Udupi Karnataka

Udupi
KARNATAKA
574118
India 
Phone  9496354350  
Fax    
Email  sushanth.anagha@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ramadevi G  
Designation  Professor and HOD 
Affiliation  SDM College of Ayurveda  
Address  Department of Prasuti Tantra and Stree Roga SDM College of Ayurveda Kuthpady Udupi Karnataka

Udupi
KARNATAKA
574118
India 
Phone  9449937158  
Fax    
Email  dr.ramadevig@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anagha S 
Designation  Part time PhD Scholar  
Affiliation  SDM College of Ayurveda 
Address  Department of Prasuti Tantra and Stree Roga SDM College of Ayurveda Kuthpady Udupi Karnataka

Udupi
KARNATAKA
574118
India 
Phone  9496354350  
Fax    
Email  sushanth.anagha@gmail.com  
 
Source of Monetary or Material Support  
Dr Anagha S Part time PhD Scholar Department of Prasuti Tantra and Stree Roga SDM College of Ayurveda Kuthpady Udupi Karnataka Pin 574118 
 
Primary Sponsor  
Name  Dr Anagha S  
Address  SDM College of Ayurveda Kuthpady Udupi Karnataka  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anagha S   Room number 1 Department of Prasuti Tantra and Stree Roga  Sri Dharmasthala Manjunatheshwara College of Ayurveda Kuthpady Udupi Karnataka
Udupi
KARNATAKA 		 9496354350

sushanth.anagha@gmail.com 
Dr Anagha S   Room number 20 and 21 Department of Prasuti Tantra and Stree Roga   SDM College of Ayurveda and Hospital Hassan Karnataka
Hassan
KARNATAKA 		 9496354350

sushanth.anagha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee SDM College of Ayurveda Udupi  Approved 
Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan  Submittted/Under Review 
 
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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: , Procedure details: )
2Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Kashyapa Samhita, Procedure details: Virechana Karma followed by internal medications)
(1) Medicine Name: Vasadi dravya Kashaya , Reference: Anubhoota yoga, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 50(ml), Frequency: bd, Duration: 3 Months
3Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Kashyapa Samhita, Procedure details: Virechana karma followed by internal medications )
(1) Medicine Name: Sarasijamakarandadi choorna , Reference: Sahasrayogam, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: bd, Duration: 3 Months
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Menstrual bleeding for more than five days in each cycle
Intermenstrual bleeding
Patient using more than three completely soaked pads per day
Subjects with signs and symptoms of Asrgdara for atleast three months
Subjects aged between 18-40years
Both married and unmarried
Subjects who are fit for Virechana randomly taken for the study
Subjects willing to sign informed consent 
 
ExclusionCriteria 
Details  Subjects who are having Coagulation disorders or bleeding disorders
Subjects using Intra uterine contraceptive device or contraceptive pills
Systemic illnesses like DM,HTN , Hyperthyroidism
Subject with known case of malignant growth in uterus or any organic pathology like cervical erosion, fibroid uterus,adenomyosis, PID
Subjects whose Hb% is less than 8gm% 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Effectiveness of Vasadi Dravya Kashaya, Sarasijamakarandadi choorna, Virechana in the management of Asrgdara  30th, 60th, 90th, 120th,150th day 
 
Secondary Outcome  
Outcome  TimePoints 
Effectiveness of Vasadi Dravya Kashaya, Sarasijamakarandadi choorna, Virechana in the management of Asrgdara  30th,60th,90th day 
 
Target Sample Size   Total Sample Size="135"
Sample Size from India="135" 
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)   27/02/2025 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sushanth.anagha@gmail.com].

  6. For how long will this data be available start date provided 01-12-2027 and end date provided 01-12-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Asrgdara is characterized by excessive and prolonged blood loss during menstruation. It is caused due to the excessive indulgence in Vata-Pitta vardhaka ahara and vihara which leads to the quantitative increase of rakta in the garbhasaya gatha sira and in turn leading to increase in the amount of artava. If Asrgdara is not treated properly, it can lead to various complications like dourbalya, bhrama, murcha, pandutva, and severe disorders of vata ¹ Asrgdara with its signs and symptoms can be correlated with Dysfunctional uterine bleeding (DUB). The term DUB refers to a state of abnormal uterinebleeding without any clinically detectable organic, systemic and iatrogenic causes. This condition is reported to occur in 9-14% women between menarche and menopause. For excessive bleeding in modern medicine treatment modalities like hormonal therapy, prostaglandin synthetase inhibitors, anti fibrinolytic agents, surgical interventions like ablative techniques, hysterectomy, etc. are prescribed. But these are expensive and have limitations in treatment of reproductive age group. Hence there is a need to adopt a harmless therapy, which is easily available, cost effective and to cure Asrgdara. The first line of treatment for Asrgdara is to control the excessive bleeding and the drugs should be mainly sheeta virya, tikta, kashaya rasa which acts as stambhaka. This study have been designed in such a way to find out the clinical efficacy of effectiveness of Vasadi dravya kashaya, Sarasijamakarandadi Choorna, Virechana in the management of Asrgdara. 
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