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CTRI Number  CTRI/2025/04/084348 [Registered on: 08/04/2025] Trial Registered Prospectively
Last Modified On: 05/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   CLINICAL STUDY OF PALASHWALKA KWATHA WITH SHARKARA IN THE MANAGEMENT OF RAKTAPRADAR WITH SPECIAL REFERANCE TO MENORRHAGIA 
Scientific Title of Study   A RANDOMIZED CONTROLLED OPEN LABELLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF PALASHWALKA KWATHA WITH SHARKARA IN THE MANAGEMENT OF RAKTAPRADAR WITH SPECIAL REFERANCE TO MENORRHAGIA 
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 Komal Santosh Kasliwal 
Designation  PG Scholar 
Affiliation  Government Ayurved College and Hospital,Nanded 
Address  Department of Prasutitantra stree rog Government Ayurved College and Hospital Vazirabad Nanded, maharashtra, India 431601

Nanded
MAHARASHTRA
431601
India 
Phone  8600565541  
Fax    
Email  kasliwal.komal1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Komal Santosh Kasliwal 
Designation  PG Scholar 
Affiliation  Government Ayurved College and Hospital,Nanded 
Address  Department of Prasutitantra stree rog Government Ayurved College and Hospital Vazirabad Nanded, maharashtra, India 431601

Nanded
MAHARASHTRA
431601
India 
Phone  8600565541  
Fax    
Email  kasliwal.komal1@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Manjusha Rupchand Meshram 
Designation  Assistant Professor 
Affiliation  Government Ayurved College and Hospital,Nanded 
Address  Department of Prasutitantra stree rog Government Ayurved College and Hospital Vazirabad Nanded,Maharashtra, India 431601

Nanded
MAHARASHTRA
431601
India 
Phone  9657017483  
Fax    
Email  drmanjushameshram@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurved College and Hospital Vazirabad Nanded pin-431601 Maharashtra India 
 
Primary Sponsor  
Name  Dr Komal Santosh Kasliwal 
Address  Department of Prasuti tantra and Stree rog Government Ayurved College and Hospital Vazirabad Nanded maharashtra, India 431601 
Type of Sponsor  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 Komal Santosh Kasliwal   Goverment Ayurved College and Hospital Nanded  Department of Prasutitantra and Stree rog Government Ayurved College and Hospital Vazirabad Nanded
Nanded
MAHARASHTRA 		 8600565541

kasliwal.komal1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical committee Government ayurved college nandedGovernment ayurved college nanded  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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: PALASHWALKA KWATHA, Reference: ASHTANGHRIDYA, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: SHARKARA), Additional Information: -
2Comparator Arm (Non Ayurveda)-TRANEXAMIC ACIDOral dose of 500mg bd in tablet form after meal for 5 days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Diagnosed cases of Raktapradar.
1)Age – 20 to 40 year married and unmarried female.
2)Patient with every socioeconomical status.
 
 
ExclusionCriteria 
Details  1)Patient having genital malignancy.
2)Patient having IUCD.
3)Patient having Uterine fibroid and other pelvic pathologies .
4)Patient suffering from severe anemia , STD.
5)Patient suffering from Acute medical condition and other systemic disorders for example Hypertension,Coagulation disorder.
6)Patient having history of currently taking OC PILLS, Harmonal therapies .
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study the efficacy of Palashwalka kwatha with Sharkara   7 Day  
 
Secondary Outcome  
Outcome  TimePoints 
No Any  No 
 
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 2/ Phase 3 
Date of First Enrollment (India)   16/04/2025 
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="2"
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 - NO
Brief Summary   This Study is Randomised controlled clinical study to evaluate the efficacy of Palashwalka Kwatha with Sharkara in the management of raktapradar. Oral administration of Palashwalka kwatha with Sharkara 40ml Twice a day before meal from 2nd day of menstruation for 7day Follow up on 9th day of menses  for 3 consecutive menstrual cycle effect in Raktapradar (Menorrhagia).this study will be carried out in 2 years of PG course. 
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