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CTRI Number  CTRI/2019/01/017024 [Registered on: 09/01/2019] Trial Registered Prospectively
Last Modified On: 03/03/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [TREATMENT]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF KANYALOHADI VATI (herbo mineral tablet) AND NASHTAPUSHPANATAKA RASA (herbo mineral tablet) IN ARTHAVAKSHAYA (Hypo (decreased ) and Oiligo (increased interval between two cycle) 
Scientific Title of Study   A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF KANYALOHADI VATI AND NASHTAPUSHPANATAKA RASA IN ARTHAVAKSHAYA  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR Shilpa 
Designation  PG Scholar 
Affiliation  Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre 
Address  Department of Prasooti Tantra and Stree Roga, 2nd Floor, Room No 10, Pipeline Road, No 10, RPC Layout Vijayanagar Bengaluru

Bangalore
KARNATAKA
560104
India 
Phone  9538697823  
Fax    
Email  shilpagmath9538@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR PAPIYA JANA 
Designation  professor 
Affiliation  Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre 
Address  Department of Prasooti Tantra and Stree Roga, 2nd Floor, Room No 10 Pipeline Road No 10 RPC Layout Vijayanagar Bengaluru

Bangalore
KARNATAKA
560104
India 
Phone  9886716216  
Fax    
Email  drpapiya@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR Shilpa 
Designation  P G Scholar 
Affiliation  Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre 
Address  Department of Prasooti Tantra and Stree Roga, 2nd Floor, Room No 10 Pipeline Road No 10 RPC Layout Vijayanagar Bengaluru

Bangalore
KARNATAKA
560104
India 
Phone  9538697823  
Fax    
Email  shilpagmath9538@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  DR Shilpa 
Address  Department of Prasooti Tantra and Stree Roga, 2nd Floor, Room No 10 Pipeline Road No 10 RPC Layout Vijayanagar Bengaluru  
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NOT APPLICABLE 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR PAPIYA JANA  Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre  Department of Prasooti Tantra and Stree Roga, 2nd Floor, Room No 10 Pipeline Road No 10 RPC Layout Vijayanagar Bengaluru
Bangalore
KARNATAKA 		 9886716216

drpapiya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SKAMCH & RC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N915||Oligomenorrhea, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  KANYALOHADI VATI   KANYALOHADI VATI FOR A PERIOD OF 2 MONTHS 1 TAB TWICE DAILY AFTER FOOD WITH LUKE WARM WATER 
Comparator Agent  NASHTAPUSHPANTAKA RASA   NASHTAPUSHPANTAKA RASA FOR A PERIOD OF 2 MONTHS 1 TAB TWICE DAILY AFTER FOOD WITH LUKE WARM WATER 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Patients of age between 16-35yrs
Duration of menstrual flow less than 2 days.
Reduced quantity of menstrual flow(using less than 1-2pads per day.)
Interval between 2 cycles exceeding more than 35 days.

 
 
ExclusionCriteria 
Details  Lactating mother.
Women taking ocp or having iucd.
Patients with h/o systamic disorders that may interfering with the course of treatment
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
EFFICACY OF INTERVENTION OVER SUBJECTIVE CRITERIA OF ARTHAVA KSHAYA  60 days Patients
30 Days Fallow UP 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NOT APPLICABLE 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   10/01/2019 
Date of Study Completion (India) 10/11/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="3"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 NOT YET PUBLISHED 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  		 ARTHAVA KSHYA IS ARTHAVAVAHA SROYODUSHTI VIKARA. IT IS CAUSED DUE TO VITTIATION OF VTA DOSHA AND KAPHA DOSHA . ABOUT 50% OF WOMEN IN THEIR REPRODUCTIVE LIFE , SUFFER FROM IRREGULAR AND CANTY MENSTRUATION.      ACHARYA SUSHRUTA HAS EXPLAINED SAMANYA CHIKITSA FOR ARTHAVA KSHAYA  AS SAMSHODANA AND AGNEYA DRAVYA PRAYOGA.ACHARYA SUSHRUTA HAS EXPLAINED ARTHAVA KSHAYA IN SUSHRUTA SAMHITA .KANYALOHADI VATI IS MENTIONED IN RASA TANTRA SARA SIDDHA PRAYOGA SANGRAHA PRATHAMA KHANDA. NASHTAPUSHPANTAKA RASA IS MENTIONED IN BHAISHAJYA RATNAVALI YONI ROGADHIKARA.THIS STUDY IS SIMPLE RANDOMIZED COMPARATIVE CLINICAL STUDY COMPARING THE EFFICACY OF KANYALOHADI VATI AND NASHTAPUSHPANATAKA RASA IN ARTHAVAKSHAYA EACH GROUP WHICH INCULDES THE CLASSICAL SIGNS AND SYMPTOMS OF ARTHAVA KSHAYA.THIS STUDY WILL BE CONDUCTED IN SRI KALABYRAVESHWARA SWAMY AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER BENGALURU KARNATAKA 
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