| CTRI Number |
CTRI/2024/10/074613 [Registered on: 01/10/2024] Trial Registered Prospectively |
| Last Modified On: |
19/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurveda Management of disturbed fat metabolism W S R to increased triglyceride levels with Trikatu churna |
|
Scientific Title of Study
|
Effect of Trikatu choorna in the management of Medo Dushti W.S.R to Primary Hyper Triglyceridemia An open lable clinical trial |
| Trial Acronym |
Disturbed fat metabolism |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pradnya Prakash Hemke |
| Designation |
PG Scholar |
| Affiliation |
Kahers Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka 590003 |
| Address |
Department of Dravyaguna KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belgavi Karnataka 590003
Belgaum KARNATAKA 590003 India |
| Phone |
9405747253 |
| Fax |
|
| Email |
pradnyahemke98@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Arun Chougale |
| Designation |
Professor and HOD of Department of Dravyaguna |
| Affiliation |
Kahers Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka 590003 |
| Address |
Department of Dravyaguna KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belgavi Karnataka 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 of Department of Dravyaguna |
| Affiliation |
Kahers Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka 590003 |
| Address |
Department of Dravyaguna KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belgavi Karnataka 590003
KARNATAKA 590003 India |
| Phone |
9964749993 |
| Fax |
|
| Email |
punarjeevam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kahers Shri BMK Ayurveda Mahavidyalaya Shahapur Belgavi Karnataka, India 590003 |
|
|
Primary Sponsor
|
| Name |
Dr Pradnya Prakash Hemke |
| Address |
KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belgavi Karnataka 590003 |
| 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 Pradnya Prakash Hemke |
KLE Shri B M K Ayurveda Hospital |
Vishuddha,OPD no 3,KLE Ayurveda Hospital,Shahapur,Belgavi Karnataka, India 590003 Belgaum KARNATAKA |
9405747253
pradnyahemke98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Insitutional Ethics Committee for Research on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E781||Pure hyperglyceridemia. Ayurveda Condition: MEDOVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trikatu Churna, Reference: Bhavprakash Nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 42 Days, anupAna/sahapAna: Yes(details: -Warm Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Triglyceride level-Borderline 150-199mg/dl
Individuals of either sex between 20-60 years of age
BMI-More than 25
Individual fulfilling subjective criteria
|
|
| ExclusionCriteria |
| Details |
Thyroid disorder
Hypertension
Diabetes
Kidney disease
Other systemic and genetic disease
Pregnant and lactating women
Grishma rutu
Pitta prakopita individual
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate efficacy of Trikatu churna in Medo dushti through triglyceride levels. |
Baseline and 42nd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess improvement in other lipid parameters along with subjective parameters. |
Baseline 21st day and 42nd day |
|
|
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)
|
01/01/2025 |
| 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
|
The term dyslipidaemia denotes disorders of lipid metabolism
Majority of the population is following inappropriate fatty diet regimen and
sedentary lifestyle which may lead to a state of dyslipidaemia Dyslipidaemia
denotes the state where there can be overproduction or decrease in production
of lipoprotein The crude HTG prevalence rates were 29.6% in global population 36.9%
in men and 23.8% in women The sex and age adjusted HTG prevalence rates were
27.0% in global population34.6% in men and 21.4% in women A fifth of the female
adult population and more than a third of the male population had HTG The
prevalence rates of various fasting dyslipidaemia in the first phase of ICMR
INDIAN study restricted to urban and rural populations in 4 states in India was
hypercholesterolemia in 13.9%, high triglycerides in 29.5% low HDL cholesterol
in 72.3% and high LDL cholesterol in 11.8% 79%men and women had abnormalities
in at least one of the lipid parameters Triglycerides are fatty acids and
denotes the main lipid component of dietary fat They store unused calories and
provide your body with energy According
to AMERICAN HEART HEALTH(AHA)factors affecting the triglyceride includes Diet
Exercise level Diabetes Inflammatory
disease Alcohol consumption Obesity
Medications Age Sex
Pregnancy The normal level of
triglycerides in blood 150mg/dl (Acc National Cholesterol Education Program
Adult Treatment Panel III) Normal <150 Borderline 150-199 High 200-499 Very high >500
Hypertriglyceridemia (HG) is an independent risk factor with more prevalence
than hypercholesterolemia and its attributes to cardiovascular disease (CVD)
and pancreatitis Hence it becomes imperative to search for new triglyceride
(TG) lowering agents In Ayurveda medodushti is pathological event which causes
sthoulya which comes under Ashtanindita The Ayurvedic description of Medodushtijanya
Sign and Symptoms bears a remarkable resemblance
to the current texts explanation of dyslipidemia As stated According to Ayurveda a diet high in
Shleshma Vardhak Ahara Vihara and low in exercise lead to Agnidushti which in
turn causes an excess of Sama Meda to form
As a result Medovriddhi and Medodushti
appears Acharya Sushruta explained TRIKATU which
consist of 3 drugs PIPALLI (PIPER LONGUM)
MARICH (PIPER NIGRUM) SHUNTHI (ZINGIBER OFFINCINALE) as kaphomedaghna Sharangdhar explains trikatu as dipana
shleshma MEDOGHNA6 kushta pinasnashanam which means drugs which do agni dipana
and reduces excess of meda The drugs present in trikatu mainly has KATU RASA
and USHNA VEERYA Katu rasa will scrape
the meda in the strotas and usna veerya will do pachan of the meda Building certainty on simple formulation and
minimal expenses with high compelling treatment is need of the time Keeping this in view trikatu choorna capsule
with compelling dose is considered for the ongoing review |