| CTRI Number |
CTRI/2024/09/073699 [Registered on: 10/09/2024] Trial Registered Prospectively |
| Last Modified On: |
17/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Evaluate the effect of Vachaharidradi Ghana Vati in the management of High Cholesterol |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial to evaluate the effect of Vachaharidradi Ghana Vati in the management of Dyslipidemia |
| 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 K R Sreeranjani |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Room no 17 Department of Kayachikitsa Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Chennai Thiruvallur Tamilnadu 600123 India
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9940051583 |
| Fax |
|
| Email |
sreeranjani2402@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suvendu Rout |
| Designation |
Professor |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Room no 17 Department of Kayachikitsa Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Chennai Thiruvallur Tamilnadu 600123 India
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9444881980 |
| Fax |
|
| Email |
drsrout@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K R Sreeranjani |
| Designation |
Post Graduate Student |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Room no 17 Department of Kayachikitsa Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarthpet Chennai Thiruvallur Tamilnadu 600123 India
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9940051583 |
| Fax |
|
| Email |
sreeranjani2402@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai, Tamil Nadu, India 600123 |
|
|
Primary Sponsor
|
| Name |
Dr K R Sreeranjani |
| Address |
Room No 17 Department of Kayachikitsa Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Chennai Thiruvallur Tamilnadu 600123 India |
| 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 K R Sreeranjani |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
Room no 17 Department Of Kayachikitsa Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Chennai Thiruvallur Tamilnadu 600123 India
Thiruvallur
TAMIL NADU |
9940051583
sreeranjani2402@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Jayendra Saraswathi Ayurveda College and Hospital |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Lekhaniya Mahakashaya Ghana Vati, Reference: Charaka Samhitha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: ushna jala), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vachaharidradhi Ghana Vati, Reference: Ashtanga Hrudaya, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: ushna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
subjects between age of 18 to 64 years of age.
Patients Fulfilling the diagnostic and pre diagnosed patients with dyslipidemic range
total cholestrol 200 to 239 mg per dl
LDL 129 to 159 mg per dl
Triglyceride 150 to 199 mg per dl
HDL less than 40 mg per dl
QRISK Value less than 10 percentage |
|
| ExclusionCriteria |
| Details |
known case of primary dyslipidemia, coronary artery disease, cerebrovascular accident, peripheral artery disease
carcinomas renal disorders like chronic kidney disease and nephrotic syndrome
hepatic disorders like liver cirrhosis, steatotic liver disease, hypothyroidism, hypertension, diabetes mellitus
Dyslipidemia due to consumption of drugs like glucocorticoids and diuretics
pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Lipid Profile |
31 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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 3 |
|
Date of First Enrollment (India)
|
10/09/2024 |
| 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
|
Dyslipidemia is manifested by the elevation of total cholestrol low density lipoprotein cholestrol triglycerides and a decrease in the high density lipoprotein cholestrol Dyslipidemia has no specific signs and symptoms In Ayurveda the concept of Dyslipidemia goes in parallel with Medorogam. Ati Santarpana leads to Kapha Vriddhi; Dushti of Rasa and Medo Dhathu. Medorogam occurs due to Medo Dhathu Dushti which causes Medo Dhathvagni Mandhyam. The treatment should aim at Apatarpana, Ama Pachana, Srotoshodhana and Kapha Medohara Chikitsa which helps in attaining Samyata of Dosha and Dushya. VachaHaridradi Gana contains Vacha, Musta, Devadaru, Nagara, Ativisha, Haritaki, Haridra, Daruharidra, Yashtimadhu, Prishniparni and Kutaja. It is Katu, Tikta Rasayuktha. Due to Laghu Ruksha Guna, it does Medoshoshana; it is Ushna in Virya and Katu in Vipaka and Kapha Medahara in nature. It is Pachana, Deepanam, Kleda-Meda Shoshaka, Srotovishodaka and Lekhana in nature. It is found that drugs like Vacha, Musta and Ativisha have hypolipidemic properties. |