| 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
590003Â 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
590003Â 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
590003Â 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patient Undergoing Vasantika Vamana |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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. |