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CTRI Number  CTRI/2024/08/072724 [Registered on: 20/08/2024] Trial Registered Prospectively
Last Modified On: 18/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Management of reduced and delayed menstrual flow with Ayurveda medicine 
Scientific Title of Study   A Single Arm Clinical Trial to Evaluate the Artava Janaka properties of Kashmarya Kshudrasaha Granules in the Management of Vataja Artava Dushti W.S.R to Oligohypomenorrhoea 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Meghna Vaman Nayak 
Designation  P.G.Scholar (Pre MS) 
Affiliation  Yashwant Ayurvedic College, Post Graduate Training and Research Centre 
Address  Department of Prasuti Tantra and Stri-roga, OPD section- OPD no 8, Yashwant Ayurvedic College, Post Graduate Training and Research Centre, Kodoli. Tal: Panhala, Dist: Kolhapur

Kolhapur
MAHARASHTRA
416114
India 
Phone  9637066564  
Fax    
Email  meghnanayak1698@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Meghna Vaman Nayak 
Designation  P.G.Scholar (Pre MS) 
Affiliation  Yashwant Ayurvedic College, Post Graduate Training and Research Centre 
Address  Department of Prasuti Tantra and Stri-Roga, OPD- section, OPD no. 8,Yashwant Ayurvedic College, Post Graduate Training and Research Centre, Kodoli. Tal: Panhala, Dist: Kolhapur

Kolhapur
MAHARASHTRA
416114
India 
Phone  9637066564  
Fax    
Email  meghnanayak1698@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vishala Turlapati 
Designation  HOD 
Affiliation  Yashwant Ayurvedic College, Post Graduate Training and Research Centre 
Address  Department of Prasuti Tantra and Stri-Roga, Yashwant Ayurvedic College, Post Graduate Training and Research Centre, Kodoli. Tal: Panhala, Dist: Kolhapur

Kolhapur
MAHARASHTRA
416114
India 
Phone  9960217429  
Fax    
Email  vishalaturlapati@gmail.com  
 
Source of Monetary or Material Support  
Yashwant Ayurvedic College, Post Graduate Training and Research Centre, Kodoli. Tal: Panhala, Dist: Kolhapur 416114 
 
Primary Sponsor  
Name  Meghna Vaman Nayak 
Address  Department of Stri-Roga and Prasuti Tantra, OPD 8, Yashwant Ayurvedic College, Post Graduate Training and Research Centre, Kodoli. Tal: Panhala, Dist: Kolhapur 416114  
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 
DrMeghna Vaman Nayak  Yashwant Ayurvedic College, Post Graduate Training and Research Centre, Kodoli.   OPD-8, Section in Hopital Campus, Department of Prasuti Tantra And Stri Roga Department, Tal: Panhala, Dist: Kolhapur 416114
Kolhapur
MAHARASHTRA 		 9637066564

meghnanayak1698@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Yashwant Ayurvedic College, Post Graduate Training and Research Centre,Kodoli,Kolhapur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N913||Primary oligomenorrhea. Ayurveda Condition: VATAJA-ARTAVADUSHTIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: KASHMARYA KSHUDRASAHA GRANULES, Reference: Ashtanga Sangraha Sharirasthana Adhyaya 1, Route: Oral, Dosage Form: Khanda /Granules, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: 40 ml Milk), Additional Information:
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  19.00 Year(s)
Gender  Female 
Details  •All female patients in the Age group of 13-19 years who are willing to participate in the study who are having symptoms of vataja artava dushti.
•With symptoms of oligo-hypomenorrhea i.e. inter-menstrual duration more than 35 days and menstrual bleeding flow less than 2 days.
•Female patients irrespective of caste, education, income group and any occupation will be selected.
•Hemoglobin 9 g % and above.
•BMI – 18-27.
 
 
ExclusionCriteria 
Details  •K/C/O of any major systemic diseases.
•K/H/O of Mullerian Duct Anomalies.
•Intermenstrual duration more than 60 days.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Artava Janana Effect of kashmarya- kshudrasaha granules in vataja artava dushti W.S.R. to Oligo-hypomenorrhoea on the basis of Pictoral Blood Assessment Chart, artava srava swaroopa chart, artava srava kalaavdhi chart, duration between two artava darshana both before and after treatment.  3 menstrual cycles 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in Vataja artava dushti condition i.e. improving the amount of menstrual bleeding & reducing the inter-menstrual duration.  3 menstrual cycles 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   30/08/2024 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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
Modification(s)  
This is a Single Arm Clinical Trial to Evaluate the Artava Janaka properties of Kashmarya Kshudrasaha Granules in the Management of Vataja Artava Dushti W.S.R to Oligohypomenorrhoea.
70 patients selected according to inclusion criteria will be administered with kashmarya-kshudrasaha granules orally mixed with milk twice a day in a single dose of 1 karsha (10g) for 3 menstrual cycles.
The Primary outcome measures will be improvement in the amount of menstrual bleeding & reducing the inter-menstrual duration. This will be assessed by subjective parameters i.e. Artava srava swaroopa (Appearance of menstrual blood),Artavasrava Kalaavadhi (Duration of Menstrual Flow) & Duration of Artava darshan (Interval between two cycles) and subjective parameter i.e. by comparing the changes in Pictorial Blood Chart before and after treatment. The total duration of the study is 18 months. 
 
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