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CTRI Number  CTRI/2026/02/103103 [Registered on: 05/02/2026] Trial Registered Prospectively
Last Modified On: 04/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Oral administration of a Herbal Medicine in Women with scanty and Infrequent Menstrual Cycle 
Scientific Title of Study   Evaluation of the Efficacy of Polyherbal formulation In the Treatment Of Artavakshaya (Oligohypomenorrhea): A Single Arm 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  Shraddha Chavhan 
Designation  M. S. Scholar Streeroga- Prasuti Tantra 
Affiliation  Dr. D. Y. Patil College of Ayurved And Research Centre Pimpri Pune 
Address  OPD NO 2 Dr D Y Patil College of Ayurved And Research Centre Pimpri Pune Maharashtra Pin Code 411018

Pune
MAHARASHTRA
411018
India 
Phone  09970668855  
Fax    
Email  shraddhachavhan13@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Pradnya Shirke 
Designation  M. S. Prasuti Tantra Avum Sreeroga 
Affiliation  Dr. D. Y. Patil College of Ayurved And Research Centre Pimpri Pune 
Address  OPD NO 2 Dr D Y Patil College of Ayurved And Research Centre Pimpri Pune Maharashtra Pin Code 411018

Pune
MAHARASHTRA
411018
India 
Phone  9623446110  
Fax    
Email  pradnyashirke2@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shraddha Chavhan 
Designation  M. S. Scholar Streeroga- Prasuti Tantra 
Affiliation  Dr. D. Y. Patil College of Ayurved And Research Centre Pimpri Pune 
Address  OPD NO 2 Dr D Y Patil College of Ayurved And Research Centre Pimpri Pune Maharashtra Pin Code 411018

Pune
MAHARASHTRA
411018
India 
Phone  09970668855  
Fax    
Email  shraddhachavhan13@gmail.com  
 
Source of Monetary or Material Support  
Dr. D. Y. Patil College of Ayurved and Research Centre Pimpri Pune 411018 
 
Primary Sponsor  
Name  Dr. Shraddha Chavhan 
Address  Dr. D. Y. Patil College of Ayurved and Research Centre Pimpri Pune Maharashtra 411018 
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 
Shraddha Chavhan  Dr. D. Y. Patil College of Ayurved And Research Centre Pimpri Pune  OPD NO 2 Streeroga and Prasutitantra OPD, Dr D Y Patil College of Ayurved And Research Centre Pimpri Pune Maharashtra Pin Code 411018
Pune
MAHARASHTRA 		 09970668855

shraddhachavhan13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DR DYPCA AND RC INSTITUTIONAL ETHICS COMMITEE PIMPRI PUNE 411018  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N914||Secondary oligomenorrhea. Ayurveda Condition: ARTAVAKSHAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Polyherbal Formulation, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Luke Warm Water), Additional Information: Polyherbal formulation contents Shatapushpa, Kumari, Jiraka, Ashoka.
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Duration of menstrual bleeding flow for 2 days or less for 3 consecutive cycles.
Patient with reduced quantity of menstrual flow for 3 consecutive cycles.
Patient with increased intermenstrual period, more than 35 days for 3 consecutive cycles. 
 
ExclusionCriteria 
Details  Patients suffering with any systemic diseases like severe Anemia(Hb less than 7 g/dl), Tuberculosis, or any type of Malignancy.
Known cases of Endocrine disorder like Hypothyroidism, Cushing syndrome or other structural abnormalities like Asherman syndrome.
Known allergy or hypersensitivity to any component of the drug being used.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in amount of menstrual bleeding, cycle regulation and reduction in pain.
 		 4 gm drug in powder form 2 times a day orally after meal for 60 days
 
 
Secondary Outcome  
Outcome  TimePoints 
A safe and effective Ayurvedic alternative to modern hormonal therapies.
 		 4 gm drug in powder form 2 times a day orally after meal for 60 days
 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
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)   01/03/2026 
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="8"
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 single arm clinical study. The aim of this study to evaluate the efficacy of polyherbal formulation in treatment of Artavaksahya (Oligohypomenorrhea). Polyherbal formulation contents Shatapushpa, Kumari, Jiraka, Ashoka. Total 38 participants will be enrolled in single group. The age group for study is 16 yrs to 40 yrs female participant. The final conclusion will be drawn on the basis of statistical methods. 
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