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CTRI Number  CTRI/2023/02/050007 [Registered on: 23/02/2023] Trial Registered Prospectively
Last Modified On: 22/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Clinical Study of Vyoshadya Saktu and Tryushanadi Guggulu in Medodushti wsr to Dyslipidemia  
Scientific Title of Study   A Clinical Study to Evaluate The Efficacy of Vyoshadya Saktu and Tryushanadi Guggulu in The Management of Medodushti wsr to Dyslipidemia  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bhanu Pratap Patel 
Designation  PG Scholar, Department of Kayachikitsa 
Affiliation  Shri Narayan Prasad Awasthi Government Ayurved College, Raipur,CHHATTISGARH 
Address  OPD Number 2,18 IPD in the Department of Kayachikitsa Shri Narayan Prasad Awasthi Government Ayurved College, Raipur,CHHATTISGARH 492010

Raipur
CHHATTISGARH
492010
India 
Phone  7987824964  
Fax    
Email  bhanupatel128@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrAruna Ojha 
Designation  Professor Department of Kayachikitsa 
Affiliation  Shri Narayan Prasad Awasthi Government Ayurved College, Raipur CHHATTISGARH 
Address  OPD Number 2,18 IPD Department of Kayachikitsa Shri Narayan Prasad Awasthi Government Ayurved College, Raipur CHHATTISGARH 492010

Raipur
CHHATTISGARH
492010
India 
Phone  9424401858  
Fax    
Email  arunaojha90@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrAjay Mohan Sahai 
Designation  Medicine Specialist 
Affiliation  Shri Narayan Prasad Awasthi Government Ayurved College, Raipur CHHATTISGARH 
Address  Sahai hospital and research center Priyadarshini nagar, Raipur CHHATTISGARH

Raipur
CHHATTISGARH
492010
India 
Phone  7898050000  
Fax    
Email  drajaymohansahai@gmail.com  
 
Source of Monetary or Material Support  
Department of Kayachikitsa Shri Narayan Prasad Awasthi Govt. Ayurved College Raipur CHHATTISGARH 
 
Primary Sponsor  
Name  Department of Kayachikitsa Shree Narayan Prasad Awasthi Govt Ayurved College Raipur CHHATTISGARH 
Address  Shri Narayan Prasad Awasthi Government Ayurved College Raipur CHHATTISGARH 
Type of Sponsor  Other [Government NPA Ayurved College,Raipur] 
 
Details of Secondary Sponsor  
Name  Address 
Department of Kayachikitsa Shri Narayan Prasad Awasthi Govt Ayurved College Raipur CHHATTISGARH  Shri Narayan Prasad Awasthi Govt. Ayurved College Raipur CHHATTISGARH 492010 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrBhanu Pratap Patel  Shri Narayan Prasad Awasthi Govt. Ayurved College Raipur CHHATTISGARH  opd no. 2 and 18 IPD Department of Kayachikitsa Shri Narayan Prasad Awasthi Govt. Ayurved College Raipur CHHATTISGARH
Raipur
CHHATTISGARH 
7987824964

bhanupatel128@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE GOVT AYURVED COLLEGE RAIPUR C.G.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:I52||Other heart disorders in diseasesclassified elsewhere. Ayurveda Condition: MEDOVAHASROTODUSHTIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: tryushanadi guggulu, Reference: bhavaprakasha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: qid, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: ushna jal), Additional Information: along with vyoshadya saktu
2Intervention ArmDrugClassical(1) Medicine Name: vyoshadya saktu, Reference: chakradutta sthaulya adhyay, Route: Oral, Dosage Form: Sattu, Dose: 53(g), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: ushna jal), Additional Information: -
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Age 25 years to 70 years patient.
following range value was taken for the diagnosis of Dyslipidemia.
1. S. Cholesterol > 200 mg/dl or/and
2. S. Triglycerides > 150 mg/dl or/and
3. S.L.D.L >130 mg/dl or/and
4. S.L.D.L >30 mg/dl or/and
5. S.H.D.L < 40 mg/dl
 
 
ExclusionCriteria 
Details 
1. Age below 25 years and above 70 years.
2. Liver cirrhosis
3. Liver failure
4. Chronic renal failure
5. Patients suffering from D.M. that were poorly controlled and uncontrolled hypertension.
6. Nephrotic syndrome
7. Tuberculosis
8. Ascites
9. Cancer.
10. Patients having H/o – Serious cardiac disorder like MI, Cardiac failure.
11. Pregnant female and lactating mothers.
12. Known cases of Immunocompromised state (AIDS)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Normalized the value of lipid profile in dyslipidemia (medodushti in ayurveda)  8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
improve the quality of life  90 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 1/ Phase 2 
Date of First Enrollment (India)   01/03/2023 
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   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Medodushti does not bear a direct reference as a disease entity in Brihattrayi, though it can be studied under the broad umbrella of Sthaulya or Medoroga, as a causative factor, aetiopathogenesis, signs and symptoms, treatment is similar for Medoroga and Medodushti.According to modern opinion, the amount of total cholesterol, triglyceride, LDL, VLDL, and HDL is abnormal in Dyslipidemia disorder. This is due to the abnormal metabolism of lipids and lipoproteins. Due to this, there is a possibility of various complex diseases like coronary heart disease (angina, ischemic heart disease, myocardial infarction) diabetes, cerebral-vascular disease, Hypertension, and atherosclerosis.In the present era, Diseases caused by improper lifestyles are more challenging. Medodushti (Dyslipidemia) is exclusively one of the lifestyle disorders because Excessive stress, lack of exercise, day sleep, junk food, canned food, soft drinks, high fatty diet, and continuous intake of high-calorie food items lead to medodushti (Dyslipidemia) and coronary artery diseases.Dyslipidemia is an established and modifiable risk factor for coronary artery disease.Drugs used in modern science to treat Dyslipidemia have several adverse effects like myopathy, the potential increase in serum transaminase levels leading to liver damage, nausea, bowel upset, etc.

More ever, drugs like statins, fibrates, resins, etc. are expensive and therefore hard for common men to purchase.So, it needs time to find out a safe and cost-effective treatment for Dyslipidemia from Ayurveda.

 

Most cases of dyslipidemia are due to the modern lifestyle full of sedentary lifestyles and unhealthy food habits.Cardiovascular Diseases (CVD) have a high disease burden in India. Dyslipidemia, a major CVD risk factor, requires effective management. Our review describes the efficacy of Vyoshadya saktu and tryushanadi guggulu in the management of medodhusti (Dyslipidemia). The prevalence of Dyslipidemia ranges from 25-30% in urban people and 15-20% in rural. It will be a single-center, nonrandomized, open‑clinical study. In this study, 60 clinically diagnosed patients of medhodhusti (Dyslipidemia) will be selected. Vyoshadya saktu will be given in doses of 50 gm saktu + 3-gram aushadhi churna three times a day with lukewarm water before a meal along with tryushanadi Guggulu in the form of vati 500mg each 2 vati four times a day for 90 days.  Statistical analysis will be done using Wilcoxon signed rank test will be using for the analysis of nonparametric data, while paired t-tests will be used for parametric data analysis.

 
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