| CTRI Number |
CTRI/2025/05/086409 [Registered on: 06/05/2025] Trial Registered Prospectively |
| Last Modified On: |
05/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Dyslipidemia management in ayurveda with dhamasa churna capsules |
|
Scientific Title of Study
|
Effect of dhamasa (Fagonia arabica Linn) churna in the management of dyslipidemia w.s.r to medodushti-An open labelled clinical trial. |
| 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 Santhosh N |
| Designation |
Post graduate scholar |
| Affiliation |
KAHERs SHRI BMK Ayurveda Mahavidyalaya |
| Address |
Department of Dravyaguna, KAHERs SHRI BMK Ayurveda Mahavidyalaya, Shahapur, Belagavi - 590003
Belgaum
KARNATAKA
590003
India |
| Phone |
8618594508 |
| Fax |
|
| Email |
santhoshgowdabelli79@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Chougale |
| Designation |
Professor and HOD Department of dravyaguna |
| Affiliation |
KAHERs SHRI BMK Ayurveda Mahavidyalaya |
| Address |
Department of Dravyaguna, KAHERs SHRI BMK Ayurveda Mahavidyalaya, Shahapur, Belagavi - 590003
Belgaum
KARNATAKA
590003
India |
| Phone |
9964749993 |
| Fax |
|
| Email |
punarjeevam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun Chougale |
| Designation |
Professor and HOD Department of dravyaguna |
| Affiliation |
KAHERs SHRI BMK Ayurveda Mahavidyalaya |
| Address |
Department of dravyaguna, KAHERs SHRI BMK Ayurveda Mahavidyalaya, Shahapur, Belagavi - 590003
Belgaum
KARNATAKA
590003
India |
| Phone |
9964749993 |
| Fax |
|
| Email |
punarjeevam@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Academy of Higher Education and Research Center, INMC Campus, Nehru Nagar, Belagavi, karnataka - 590010 |
|
|
Primary Sponsor
|
| Name |
KLE Academy of Higher Education and Research Center |
| Address |
KLE Academy of Higher Education and Research Center, INMC Campus, Nehru Nagar, Belagavi, karnataka - 590010 |
| Type of Sponsor |
Other [Deemed to be university] |
|
|
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 Santhosh N |
KLE Ayurveda Hospital, shahapur |
OPD-3, KLE Ayurveda Hospital, Shahapur, Belagavi-590003
Belgaum
KARNATAKA |
8618594508
santhoshgowdabelli79@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for research on human subjects KAHETRs SHRI BMKankanwadi Ayurveda Mahavidyalaya and KLE ayurveda hospital, Shahapur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E789||Disorder of lipoprotein metabolism, unspecified. Ayurveda Condition: MEDOVRUDDHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dhamasa , Reference: Bhavaprakasha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 42 Days, anupAna/sahapAna: Yes(details: Hot water), Additional Information: NIL |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals of Either sex between age group 20 to 60 years of age, BMI More than 25, If any of the following levels of lipid profile criteria fulfills LDL - 130 - 159mg/dl, Triglycerides - 150 - 199mg/dl, Total Cholesterol - 200 - 239mg/dl. |
|
| ExclusionCriteria |
| Details |
Individuals of age group below 20 and above 60 and having BMI below 25, LDL - greater than 159mg/dl, Triglycerides greater than 199mg/dl, Total cholesterol greater than 239mg/dl and suffering from systemic disorders like Hypertension, diabetes mellitus, Kidney disease, Genetic disorders, Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dhamasa Choorna is expected to be effective in Reducing Increased lipid profile level |
assessed on 0th day and on 42ndday i.e, on 1st week and on 6th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in BMI |
0th, 21st, 42nd days |
|
|
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 |
|
Date of First Enrollment (India)
|
15/06/2025 |
| 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="0"
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
|
Dyslipidemia has become a major worldwide health problem. Overweight and obesity are responsible for 44% of diabetes burden, 23% of ischemic heart disease burden, and 7-41% of various cancer. Around 1.9 billion persons worldwide in 2016 were overweight, with Almost 650 million people worldwide were obese. Many of these complications are related to co-morbid conditions dyslipidemia. Obesity increases cardiovascular risk through risk factors such as increased fasting plasma triglycerides, high LDL cholesterol, low HDL cholesterol, elevated blood glucose and insulin levels and high blood pressure. Around 60-70% of people with obesity have dyslipidemia. In Ayurveda dyslipidemia can be correlated with medodushti which is considered to be a disease of Medo dhatu. Therefore, Dhamasa is mentioned in Bhavaprakasha nighantu as Kaphamedajit so, it is considered for ongoing review.
|