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CTRI Number  CTRI/2026/02/103507 [Registered on: 10/02/2026] Trial Registered Prospectively
Last Modified On: 09/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study to assess the effectiveness of Malayuphal Modak in heavy menstrual bleeding during puberty. 
Scientific Title of Study   A RANDOMIZED OPEN CONTROLLED CLINICAL TRIAL TO ASSESS THE ADD ON EFFECT OF MALAYUPHALA MODAK IN TARUNI ASRUGDAR W.S.R. TO PUBERTY 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  DrVaishnavi Dnyaneshwar Ghawat  
Designation  PG SCHOLAR Streerog Evum Prasutitantra  
Affiliation  YASHWANT Ayurvedic College postgraduate Training and Research Centre Kodoli  
Address  Yashwant Ayurvedic College postgraduate Training and Research centre kodoli kolhapur
Yashwant Ayurvedic College postgraduate Training and Research centre kodoli
Kolhapur
MAHARASHTRA
416114
India 
Phone  9767435033  
Fax    
Email  vaishnavighawat1998@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrT Vishala  
Designation  Professor and HOD Streerog Evum Prasutitantra Department  
Affiliation  Yashwant Ayurvedic College postgraduate Training and Research centre Kodoli kolhapur  
Address  Yashwant Ayurvedic College postgraduate Training and Research centre Kodoli kolhapur
Yashwant Ayurvedic College postgraduate Training and Research Centre Kodoli kolhapur
Kolhapur
MAHARASHTRA
416114
India 
Phone  9960217429  
Fax    
Email  vishalaturlapati@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vaishnavi Dnyaneshwar Ghawat  
Designation  PG SCHOLAR Streerog Evum Prasutitantra Department  
Affiliation  Yashwant Ayurvedic College Postgraduate Training and Research Centre Kodoli  
Address  Yashwant Ayurvedic College Postgraduate Training and Research Centre Kodoli kolhapur
Yashwant Ayurvedic College postgraduate Training and Research Centre Kodoli kolhapur
Kolhapur
MAHARASHTRA
416114
India 
Phone  9767435033  
Fax    
Email  vaishnavighawat1998@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Dr Vaishnavi Dnyaneshwar Ghawat  
Address  Yashwant Ayurvedic College Postgraduate Training and Research Centre Kodoli kolhapur  
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 Vaishnavi Ghawat   Yashwant Dharmarth Rugnalaya Kodoli   Opd no.8 and OPD no.27 strirog prasutitantra department
Kolhapur
MAHARASHTRA 		 9767435033

vaishnavighawat1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical committee Yashwant Ayurvedic College postgraduate Training and Research Centre Kodoli   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N922||Excessive menstruation at puberty. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Malayuphal Modak , Reference: Yogratnakar , vidhyatini Hindi Tika Sahit ,Chaukhamba Sanskrut sansthan,Uttarardha adhyay 43, Shloka 15,pg 397., Route: Oral, Dosage Form: Modaka , Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Water), Additional Information: -
2Comparator Arm (Non Ayurveda)-Reassurance and ferrous AscorbateRest Reassurance and ferrous Ascorbate 100 mg once a day after food with water for 3 menstrual cycle D C Dutta, Textbook of gynaecology, 8th edition,2020, chapter 5, page no.4.
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  16.00 Year(s)
Gender  Female 
Details  1) Patients with prolonged cycle more than 7 days & excessive bleeding per vagina i.e 3-5 large sized Stayfree secure pads in 24 hours during menstruation.
2) Onset of menarche not exceeding more than 2 years at the time of registration.
3) Polymenorrhagia.
4) Inter-menstrual bleeding (Anruta artava- Chakradatta).
5) Patients with Hb-9 to 11 gm/dl.
6) Patients with BMI between 18-28 .
7) Age-10 to 16 years unmarried girls irrespective of caste, socio-economic status. 
 
ExclusionCriteria 
Details  1. Physical examination suggestive of Hirsuitism, Acanthosis Nigricans.
2. BMI more than 30.
3. K/C/O Endocrinal Disorder like Hypo or Hyperthyroidism, PCOS .
4. K/C/O Bleeding Dyscrasias.
5. K/C/O Pelvic organ pathology.
6.K/C/O systemic disorders.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the Add on effect of MALAYUPHALA MODAK along with Reassurance ferric Ascorbate in the management of Taruni Asrugdar W.S.R. to Puberty Menorrhagia.  To evaluate the Add on effect of MALAYUPHALA MODAK along with Reassurance ferric Ascorbate in the management of Taruni Asrugdar W.S.R. to Puberty Menorrhagia. 
 
Secondary Outcome  
Outcome  TimePoints 
1)To reduce amount of bleeding due to Menorrhagia
2)To assess improvement by parameters like PBAC.
3)To reduce the duration of menstural cycle due to Menorrhagia.
4)To study th etio-pathology of Asrugdar & puberty menorrhagia in detail.
5)To assess the improvement in other assessment parameter(with or without clots,Angamarda etc)
6)To achieve the outcome of study in 90 days ( 3 Menstrual cycles) by assessment of the condition in each cycle.
7)To assure post treatment cycles are symptom free. 		 1)To reduce amount of bleeding due to Menorrhagia.
2)To assess improvement by parameters like PBAC.
3)To reduce the duration of menstural cycle due to Menorrhagia.
4)To study th etio-pathology of Asrugdar & puberty menorrhagia in detail.
5)To assess the improvement in other assessment parameter(with or without clots,Angamarda etc)
6)To achieve the outcome of study in 90 days ( 3 Menstrual cycles) by assessment of the condition in each cycle.
7)To assure post treatment cycles are symptom free. 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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 
Date of First Enrollment (India)   22/02/2026 
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 - NO
Brief Summary   This is a randomized open controlled clinical study to assess the add on effect of Malayuphala modak in the management of puberty menorrhagia compare conventional treatment alone with conventional treatment plus Malayuphala modak to evaluate improvement in symptoms. Assessment symptoms will be done at regular intervals. 
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