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CTRI Number  CTRI/2024/07/070976 [Registered on: 22/07/2024] Trial Registered Prospectively
Last Modified On: 18/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Boladi Vati and Kanyalohadi Vati in Delayed and Reduced Menses(Artava Kshaya/Oligomenorrhea) 
Scientific Title of Study   A comparative clinical study to evaluate the effect of Boladi Vati and Kanyalohadi Vati in the management of Artava Kshaya (Oligomenorrhea) 
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 Roopa Sangolli 
Designation  P G Scholar 
Affiliation  Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre 
Address  OPD Department of PTSR Ground Floor SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar, Terdal 587315

Bagalkot
KARNATAKA
587315
India 
Phone  7619630980  
Fax    
Email  sangolliroopa@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vidyavati Pathak 
Designation  Professor 
Affiliation  Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre 
Address  OPD Department of PTSR Ground Floor SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar, Terdal 587315

Bagalkot
KARNATAKA
587315
India 
Phone  8310160682  
Fax    
Email  dr.vidyapattar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Roopa Sangolli 
Designation  P G Scholar 
Affiliation  Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre 
Address  OPD Department of PTSR Ground Floor SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar, Terdal 587315

Bagalkot
KARNATAKA
587315
India 
Phone  7619630980  
Fax    
Email  sangolliroopa@gmail.com  
 
Source of Monetary or Material Support  
SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar Terdal 587315 Bagalkot Karnataka India 
 
Primary Sponsor  
Name  Dr Roopa Sangolli 
Address  SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar Terdal 587315 Bagalkot Karnataka India 
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 Roopa Sangolli  Padma Ayurvedic Hospital And Research Centre  OPD Department of PTSR Ground Floor SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar, Terdal 587315
Bagalkot
KARNATAKA 		 7619630980

sangolliroopa@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SDMTs Ayurvedic Medical College And Padma Ayurvedic Hospital Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N915||Oligomenorrhea, unspecified. Ayurveda Condition: ARTAVAKSHAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Boladi Vati, Reference: Rasatantrasaar va siddhaprayog Sangraha Dvitiya Khanda Gutika Prakarana, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Sukhoshna Jala), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Kanyalohadi vati, Reference: Rasatantrasaar Va Siddhaprayog Sangraha Prathama Khanda Stree roga Prakarana, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Sukhoshna jala), Additional Information: -
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1.Menses at an interval longer than 35 days.
2.Bleeding less than 2 days
3.Both married and unmarried.
4.Reduced flow i.e. less than 1 pad per day.
5.Pain in vagina.
 
 
ExclusionCriteria 
Details  1.Pregnant and Lactating women.
2.Woman on OCPs and IUCD
3.Hb% less than 8gm
4.K/C/O Pelvic Pathology or Malignancy
5.Systemic Disease which interferes with the management of Artava Kshaya. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Effect of trial drug on improvement in the symptoms of Artava kshaya(Oligomenorrhea)  5th day of Two consecutive cycles) 
 
Secondary Outcome  
Outcome  TimePoints 
Safety of the trial drug and Adverse Drug Reaction and aggravation in the symptoms of Artava Kshaya(Oligomenorrhea)  5th day of Two consecutive cycles 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   29/07/2024 
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="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  

  • Ayurveda describes Menstrual Disorders  under the heading Astha artava dushti, Asrigdara, Artava Kshaya, Nastartava, Yoni vyapad.
  • Artava kshaya is one among them with involving Apana Vata and Kapha causing obstruction in the passage of Artava and it is characterized by Yathochita kalat adarshana(prolonged inter-menstrual cycle), Alpata(Reduced flow), Yoni Vedana(pain in vagina).
  • This can be correlated with oligomenorrhea. It is defined as menstrual bleeding occurring more than 35 days apart and which remains constant at that frequency.
  • In this study Boladi Vati  is selected as trial drug for the management of Artava Kshaya (Oligomenorrhea)and its efficacy is compared with Kanyalohadi Vati.
  • This is a randomized controlled clinical trial. Total 40 patient of Artava Kshaya who fulfil the inclusion criteria & diagnostic criteria based on clinical sign and symptoms of Artava Kshaya will be selected. Total Study duration will be 60 days and contain 3 visits (0th day, 5th day of first cycle and 5th day of second consecutive cycle), which includes administration of trial drug for 30 days for one cycle and post medication follow up on 5th day first and second consecutive cycle.
  • After study, data will be collected from case report form (CRF) and statistically analysed by using appropriate parametric and non-parametric tests and results will be obtained. On that basis results and conclusion will be drawn.

 
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