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
|
|
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
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (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 | 2 | Intervention Arm | Drug | Classical | | (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. |