FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/03/083399 [Registered on: 25/03/2025] Trial Registered Prospectively
Last Modified On: 23/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   To Check The Combined Effect of Kalyanaka Ghrita and Mustadi yapana basti in Anovulation. 
Scientific Title of Study   Clinical study to evaluate the Combined Effect of Kalyanaka Ghrita and Mustadi yapana basti in Anovulation. 
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 sangam R Byali 
Designation  Post graduate scholar 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan 
Address  Department of Prasuti tantra and Stree roga, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Hassan

Hassan
KARNATAKA
573201
India 
Phone  9845951959  
Fax    
Email  swetabyali12@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prathima 
Designation  Associate professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan 
Address  Department of Prasuti tantra and Stree roga, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Hassan

Hassan
KARNATAKA
573201
India 
Phone  9611990497  
Fax    
Email  drprathima.jain@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Prathima 
Designation  Associate professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan 
Address  Department of Prasuti tantra and Stree roga, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Hassan

Hassan
KARNATAKA
573201
India 
Phone  9611990497  
Fax    
Email  drprathima.jain@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital,B M road,Thanniruhalla,Hassan,Karnataka,PIN-573201 India Phone No-08172256460,E-mail-sdmcah@gmail.com 
 
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital,B M road,Thanniruhalla,Hassan,Karnataka,PIN-573201 India Phone No-08172256460,E-mail-sdmcah@gmail.com 
Type of Sponsor  Private medical college 
 
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 Sangam R Byali  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan  Department of prasutitantra and stree roga,Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital,B M road,Thanniruhalla,Hassan
Hassan
KARNATAKA 		 9845951959

shwetabyali12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Infertility due to Anovulation 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-yApana-bastiH, यापन-बस्तिः (Procedure Reference: Charaka samhitha, Procedure details: Mustadi yapana basti is given like yoga basti for 8 days. Niruha basti dosage:600 ml Anuvasana basti dosage:80 ml)
(1) Medicine Name: Kalyanka ghrita, Reference: Ashtanga hridaya uttarastana, Route: Oral, Dosage Form: Ghrita, Dose: 15(ml), Frequency: od, Duration: 2 Months
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1.Married women between age group of 21-35 years
2.Women diagnosed as anovulation with or without pcos
3.Patient of primary or secondary infertility due to anovulation. 
 
ExclusionCriteria 
Details  1.Patient suffering from systemic disorders such as hypertention,diabetes mellitus,thyroid dysfunction and severe anaemia

2.Reproductive tract disorders like tuberculosis and congenital anomalies or STDs

3.Diagnosed case of genetic abnormalities.

4.Diagnosed case of benign/malignant lesions of uterus/ovaries. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To induce ovulation with combined effect of orally kalyanaka ghrita and mustadi yapana yoga basti  2 months 
 
Secondary Outcome  
Outcome  TimePoints 
To rule out anovulation in married women aged between 21 to 35 years,  2 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   N/A 
Date of First Enrollment (India)   05/04/2025 
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)   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   The research title is Clinical Study to Evaluate the Combined Effect of Kalyanaka Ghrita and Mustadi Yapana Basti in Anovulation.Is a open labelled single arm clinical study which involves total of 30 participants the study includes Married women aged between 21 to 35 years,with primary or secondary infertility.And excludes Genetic abnormalities, Reproductive tract disorders.And proper case history will be taken by using case report form,by taking consent of each and every participants.The collected data and results are calculated by using statistical spss software. 
Close