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CTRI Number  CTRI/2024/08/072349 [Registered on: 12/08/2024] Trial Registered Prospectively
Last Modified On: 10/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical study to compare the effect of Krishna Tila Kashaya and Kulatthadi Kashaya in the management of Oligomenorrhea  
Scientific Title of Study   A comparative clinical study to evaluate the efficacy of Krishna Tila Kashaya and Kulatthadi Kashaya in the management of Artavakshaya 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
not applicable  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sneha D V 
Designation  UG scholar 
Affiliation  SDM Institute of Ayurveda and Hospital, Anchepalya, Bangalore, Karnataka,560074,India. 
Address  Department of Prasooti Tantra Evam Stree Roga, Ground floor, OPD No.4,5,6,24,29 Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Kumbalgodu Post, Bengaluru-560074.

Bangalore
KARNATAKA
560074
India 
Phone  9916412937  
Fax    
Email  20A4413@sdmayurbangalore.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Padmasaritha 
Designation  Professor and HOD, Department of Prasuti tantra evam striroga  
Affiliation  SDM Institute of Ayurveda and Hospital, Anchepalya, Bangalore, Karnataka,560074,India. 
Address  Department of Prasuti Tantra Evam Stree Roga, Ground floor, OPD No.24 Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Kumbalgodu Post, Bengaluru-560074.

Bangalore
KARNATAKA
560074
India 
Phone  7353254151  
Fax    
Email  padmasarithareddy@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sneha D V 
Designation  UG scholar 
Affiliation  SDM Institute of Ayurveda and Hospital, Anchepalya, Bangalore, Karnataka,560074,India. 
Address  Department of Prasuti Tantra Evam Stree Roga, Ground floor, OPD No.4,5,6,24,29. Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Kumbalgodu Post, Bengaluru-560074.

Bangalore
KARNATAKA
560074
India 
Phone  9916412937  
Fax    
Email  20A4413@sdmayurbangalore.in  
 
Source of Monetary or Material Support  
Rajiv Gandhi University of Health Sciences. 2, 30th Cross Rd, opp. Sagar Hospital, 4th T Block East, Pattabhirama Nagar, Jayanagar, Bengaluru Karnataka 560041. 
 
Primary Sponsor  
Name  Rajiv Gandhi University of health sciences 
Address  Rajiv Gandhi University of Health Sciences, Karnataka 4th T Block, Jayanagar Bengaluru - 560 041 Karnataka India 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
not applicable   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 Padmasaritha  SDM institute of Ayurveda and Hospital  Department of Prasuti Tantra Evam Stree Roga, Ground floor, OPD No.24 Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Kumbalgodu Post, Bengaluru-560074.
Bangalore
KARNATAKA 		 7353254151

padmasarithareddy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee Shri Dharmasthala manjunatheshwara institute of Ayurveda and Hospital  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: Krishna tila Kashaya, Reference: Yogaratnakara yonivyapad chikitsadhikara, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Guda-6g), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Kulatthadi kashaya, Reference: sahasrayoga, kashaya yogas, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: 30ml jala), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1.Patients aged between 18-35 years.
2.Both married and unmarried women.
3.Bleeding, spotting less than 2 days.
4.Pad used 1 per day.
5.Infrequent menses at intervals longer than 35 days.
6.Patients presenting with the Pratyatma Lakshana of Artava Kshaya. (Uchitakala Adarshana, Alpata, Yonivedana)
 
 
ExclusionCriteria 
Details  1.Patient with a systemic disorder like DM, HTN, TB, Asthma, Congenital abnormalities.
2.Patient with mal-nutrition, severe anaemia (Hb less than 8gm percent) pregnant and Lactating women, women using OCP and IUCD, congenital anomalies of uterus or ovaries
 
 
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 
The study reveals that Krishna tila Kashaya and kulatthadi kashaya effectively reduces pain, increases duration of flow, increases menstrual bleeding, reduces duration of inter menstrual period, regulates harmones and improves quality and quantity of arthava.
The research underscores the importance of adopting simple, cost effective management stratagies for arthava kshaya, reduce health care costs, improve access to care for underserved populations, and enhance overall quality of life. 		 Baseline, 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
The study emphasizes the significance of identifying alleviating factors(upashaya) in clinical practice, enabling clinicians to design personalized treatment plans that target the root cause of arthava kshaya.
As a result of normalizing arthavavaha sroto avarodha, fertility can also be improved in patients desiring fertility, regularity of further menstrual cycle 		 Baseline, 3 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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/ Phase 3 
Date of First Enrollment (India)   26/08/2024 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   A comparative clinical study to evaluate the efficacy of Krishna Tila Kashaya and Kulatthadi Kashaya in the management of Arthavakshaya, between the age group of 18-35 years. During the study period 30 patients will be recruited and divided into 2 groups. Group A (Control) with oral administration of Krishna Tila Kashaya - 40ml BD dosage with Anupana 6gm of Guda B/F and Group B (trial) with oral administration of Kulatthadi Kashaya - 10ml BD dosage with Anupana 30 ml of Ushna jala B/F except on the days of menstruation. Statistical analysis will be done on Baseline and 3 months of menstrual  cycle. 
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