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CTRI Number  CTRI/2025/02/081212 [Registered on: 24/02/2025] Trial Registered Prospectively
Last Modified On: 22/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   To Evaluate the Changes in neurotransmitters During Vamana Karma With Madanphala Yoga 
Scientific Title of Study   Evaluation of Neurotransmitters during Vamana Karma with Madanphala yoga - An Exploratory study 
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 Jyoti Lakhlan 
Designation  PG Scholar 
Affiliation  KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya And Medical Research Centre 
Address  Dept of Panchakarma, KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya and Medical Research Center Shahapur, Belagavi, Karnataka Belgaum Karnataka 590003 India

Belgaum
KARNATAKA
590003
India 
Phone  8607791210  
Fax    
Email  jyotilakhlan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vishwanath S Wasedar 
Designation  Associate Professor Dept. of Panchakarma 
Affiliation  KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya And Medical Research centre 
Address  Dept of Panchakarma , KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya And Medical Research Centre Shahapur, Belagavi, Karnataka Belgaum Karnataka 590003 India

Belgaum
KARNATAKA
590003
India 
Phone  08494946898  
Fax    
Email  drvswayurveda@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vishwanath S Wasedar 
Designation  Associate Professor Dept. of Panchakarma 
Affiliation  KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya And Medical Research centre 
Address  Dept of Panchakarma , KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya And Medical Research Centre Shahapur, Belagavi, Karnataka Belgaum Karnataka 590003 India

Belgaum
KARNATAKA
590003
India 
Phone  08494946898  
Fax    
Email  drvswayurveda@gmail.com  
 
Source of Monetary or Material Support  
KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya and Medical Research Center Shahapur Belagavi Karnataka 590003, INDIA 
 
Primary Sponsor  
Name  Dr Jyoti Lakhlan 
Address  Department of Panchakarma , KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya And Medical Research Center Shahapur Belagavi Karnataka 
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 Jyoti Lakhlan  KLE Ayurveda Hospital and Medical Research Center  OPD NO 04 of KLE Ayurveda Hospital and MRC KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka 590003
Belgaum
KARNATAKA 
8607791210

jyotilakhlan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethic Committee For Research on Human Subjects KAHERs Shri BM Kankanwadi Ayurveda Mahavidyalaya And KLE Ayurveda Hospital Shahapur Belagavi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patient Undergoing Vasantika Vamana 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-vamana karma (Procedure Reference: Procedure Reference: Charaka Samhita Siddhisthana, Procedure details: Procedure details: 10 ml Blood Sample will be collected from the patient undergoing vamana procedure on the following timepoints- 1. One day before Vamana (before taking Kaphutkleskar Ahara at 7:00 AM) 2. On day of Vamana (After Sarvanga Abhyanga & Swedana at 7:00 AM) 3. On day of Vamana (25 min after taking Madanphala yoga) 4. On day of Vamana (50 min after taking Madanphala yoga) ))
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Apparently healthy individual undergoing for vasantika vamana
Patient aged between 18 to 40 years.
Patients who are willing to give blood samples.
 
 
ExclusionCriteria 
Details  Patients contraindicated for vamana karma.
K/C/O of Hypertension, Diabetes Mellitus and other co morbidities
Pregnant and lactating women.
Any severe illness.
Patients who are not willing to give blood samples.
Patient with lactose intolerance
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
SERUM SEROTONIN LEVEL
SERUM SUBSTANCE P LEVEL
SERUM ACETYLCHOLINE LEVEL 
Day 0 at 7 AM 1 day before medicine administration
Day 1 at 7 AM before medicine administration
DAY 1 25 minutes after the medicine administration
DAY 1 50 minutes after the medicine administration
 
 
Secondary Outcome  
Outcome  TimePoints 
Understand the sequence of events in Vamana Karma (Therapeutic Emesis) such as Kaphutkleshan (Vitiated dosha) , Vamana (Emetic) Drug Action, Vamanopaga (Emetic drugs) Drug Action with respect to Neurotransmitters  Kaphutkleshan (Vitiated dosha) on day 0 & day 1 ,Action of Vamana Drug (Emetic) & Vamanopaga (Emetic drugs) Drug on day 1  
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   15/03/2025 
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 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  

Vamana karma is considered as the pradhana karma indicated for purification of upper part of body by inducing therapeutic vomiting. Amashaya and ura pradesh are the sthanas for kapha1. As per general principle of ayurveda, vitiated doshas should be expelled out through nearest route i.e. by oral route for kapha dosha.

 Many Vamaka Dravyas are mentioned in bhritrayees, among them madanphala (Randia dometorum) is considered as the best vamaka dravya (emetic drug) because of its ‘anapayikatwa guna’ means having very less complications and  is safer to use.

 Neurotransmitter are the mediators or chemical messengers which impact the induction of Vamana. This study is to create an evidence regarding changes in neurotransmitter level with respect to vamaka dravyas . In ayurveda principles, vamana is explained in terms of utklesh lakshana such as sweda pradhurbhava, lomharsh, kukshi adhyamana, hrullassa And samyak shudhhi lakshanas such as langiki, vaigiki, antiki and mainki. It is believed that neurotransmitters may play a major role in induction of vamana karma so to create an evidence this study has been initiated to visualize and create the data of impact of neurotransmitter on vamana karma with respect to usage of madanphala yoga which may guide in future.

 
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