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CTRI Number  CTRI/2025/07/090263 [Registered on: 07/07/2025] Trial Registered Prospectively
Last Modified On: 04/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study the effect of Amalaki beej churna in heavy menstrual bleeding 
Scientific Title of Study   A Randomized open labeled controlled clinical trial to assess an efficacy of Amalaki beej churna with Tandulodaka in the management of Asrugdara with special reference 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  Manasi Nitin Sonawane 
Designation  PG Student Streeroga Prasutitantra 
Affiliation  Matoshree Asarabai Darade Ayurveda Mahavidyalaya Babhulgaon Tal-Yeola Dist-Nashik  
Address  Department of Streeroga and Prasutitantra Matoshree Asarabai Darade Ayurveda Mahavidyalaya Babhulgaon Tal-Yeola Dist-Nashik Maharashtra Pin-423401

Nashik
MAHARASHTRA
423401
India 
Phone  9834636902  
Fax    
Email  manasisonawane1999@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sachin More 
Designation  Professor and Guide 
Affiliation  Matoshree Asarabai Darade Ayurveda Mahavidyalaya Babhulgaon Tal-Yeola Dist-Nashik  
Address  Department of Streeroga and Prasutitantra Matoshree Asarabai Darade Ayurveda Mahavidyalaya Babhulgaon Tal-Yeola Dist-Nashik Maharashtra Pin-423401

Nashik
MAHARASHTRA
423401
India 
Phone  9822874480  
Fax    
Email  sachinmore070979@gmail.com  
 
Details of Contact Person
Public Query  
Name  Manasi Nitin Sonawane 
Designation  PG Student Streeroga Prasutitantra 
Affiliation  Matoshree Asarabai Darade Ayurveda Mahavidyalaya Babhulgaon Tal-Yeola Dist-Nashik  
Address  Department of Streeroga and Prasutitantra Matoshree Asarabai Darade Ayurveda Mahavidyalaya Babhulgaon Tal-Yeola Dist-Nashik Maharashtra Pin-423401

Nashik
MAHARASHTRA
423401
India 
Phone  9834636902  
Fax    
Email  manasisonawane1999@gmail.com  
 
Source of Monetary or Material Support  
Matoshree Asarabai Darade Ayurveda Mahavidyalaya Babhulgaon Tal-Yeola Dist-Nashik Maharashtra Pin-423401 
 
Primary Sponsor  
Name  Manasi Nitin Sonawane 
Address  Matoshree Asarabai Darade Ayurveda Mahavidyalaya Babhulgaon Tal-Yeola Dist-Nashik Maharashtra Pin-423401 
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 
DrManasi Nitin Sonawane  Matoshree Asarabai Darade Ayurveda Mahavidyalaya Babhulgaon Tal - Yeola  Streeroga Prasutitantra OPD No 8 Ground Floor Nashik Maharashtra
Nashik
MAHARASHTRA 		 9834636902

manasisonawane1999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee  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: Amalaki beej churna, Reference: Bharat bhaishajya ratnakar part 3, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Tandulodaka), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Yashtimadhu Sita Churna, Reference: Bhavprakash Samhita Chikitsasthan adhyay 68 Shlok no 10, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Tandulodaka), Additional Information: -
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Selection irrespective of marital status, parity,
socioeconomic status.
2. Patients having signs and symptoms of Asrugdara.
3. Excessive bleeding more than 2 consecutive cycles.
4. Excessive bleeding (more than 80ml) or more than 7 days per vagina during mensuration.
5. Hb more than 7 gm percentage
 
 
ExclusionCriteria 
Details   
 
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   Open Label 
Primary Outcome  
Outcome  TimePoints 
To determine the efficacy of Amalaki Beej churna with tandulodaka in Asrugdara W.S.R. to menorrhagia   1 week,2 week,4 week,3 months  
 
Secondary Outcome  
Outcome  TimePoints 
To study control on amount and duration of bleeding
To study efficacy in reducing associated symptoms
To study etiopathology of asrugdara
To study disease according to ayurvedic or modern text books 		 7th,14th, 28th day for 3 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 
Date of First Enrollment (India)   15/07/2025 
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="1"
Months="6"
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 - Informed Consent Form
    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 [manasisonawane1999@gmail.com].

  6. For how long will this data be available start date provided 30-06-2025 and end date provided 30-06-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   This is a randomised, open-label, controlled clinical study to evaluate the efficacy of Amalaki beej churna with Tandulodaka orally in Asrugdara, which will be conducted in the OPD of Matoshri Asarabai Darade Ayurveda Mahavidyalaya, Babhulgaon. The primary outcome measures will be to assess the effect of the drug after 7th, 14th and 28th day, and the secondary outcome will be measured after 3 menstrual cycles during treatment and after 1 month after the treatment is completed. 
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