CTRI Number |
CTRI/2013/09/003952 [Registered on: 04/09/2013] Trial Registered Prospectively |
Last Modified On: |
04/09/2013 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
high lipid in blood and its management by garlic and tryoshnadi guggulu(Ayurvedic polyherbal formulation) |
Scientific Title of Study
|
A comparative clinical study of Tryoshnadi Guggulu and Lasuna in management of dyslipidemia |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Bharatkumar c Padhar |
Designation |
M D Scholar |
Affiliation |
I P G T and R A Gujarat Ayurved Unuversity Jamnagar Gujarat India |
Address |
room no 26
P G Boys hostel
I P G T and R A
Gujarat Ayurved Unuversity
Jamnagar Gujarat
India
Jamnagar GUJARAT 361008 India |
Phone |
9638435942 |
Fax |
|
Email |
dr.bharat1987@yahoo.in |
|
Details of Contact Person Scientific Query
|
Name |
Dr Mandip kaur |
Designation |
Assistant professor |
Affiliation |
I P G T and R A Gujarat Ayurved Unuversity Jamnagar Gujarat India |
Address |
Kayachikitsa department
I P G T and R A
Gujarat Ayurved Unuversity
Jamnagar Gujarat
India
Jamnagar GUJARAT 361008 India |
Phone |
9427572306 |
Fax |
|
Email |
kaurmandip22@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Dr Alankruta R Dave |
Designation |
Associate professor |
Affiliation |
I P G T and R A Gujarat Ayurved Unuversity Jamnagar Gujarat India |
Address |
Kayachikitsa department
I P G T and R A
Gujarat Ayurved Unuversity
Jamnagar Gujarat
India
Jamnagar GUJARAT 361008 India |
Phone |
9824171817 |
Fax |
|
Email |
alankruta@yahoo.com |
|
Source of Monetary or Material Support
|
I P G T and R A Gujarat Ayurved University jamnagar |
|
Primary Sponsor
|
Name |
Institute for Post Gradute Teaching and Research of Ayurved Gujarat Ayurved Universuty jamnagar |
Address |
I P G T and R A
Gujarat Ayurved Unuversity
Jamnagar Gujarat
India |
Type of Sponsor |
Research institution and hospital |
|
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 Bharat Padhar |
OPD no 21 Dept of Kayachikitsa Institute for Post Graduate Teaching and Research in Ayurveda |
Institute for Post Graduate Teaching and Research in Ayurveda
Jamnagar Jamnagar GUJARAT |
9638435942
dr.bharat1987@yahoo.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institute for post graduate teaching and research in Ayurveda Institutional Ethics Committee jamnagar gujarat |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
patients suffering from dyslipidemia, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Lasuna capsule |
Drug -Lasuna capsule (Filled with dehydrated powder of lasuna)
Form: capsule
Dose: 2 Cap. (Each Cap.400 mg.) TDS
Mode of administration : Oral
Time of administration : At morning and before lunch and meal
Anupana : water
Duration: 8 weeks
|
Comparator Agent |
Tryoshnadi guggulu |
Drug: Tryoshnadi guggulu
Form: Vati
Dose: 2 Tab (Each tab.500 mg.) TDS
Mode of administration : Oral
Time of administration : At morning and before lunch and meal
Anupana: Luke warm water
Duration: 8 weeks
|
|
Inclusion Criteria
|
Age From |
25.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Patients having age between 25 – 60 years of either sex
S. Cholesterol > 200 mg/dl or/and
S. Triglyceride > 150 mg/dl or/and
S.L.D.L >130 mg/dl or/and
S.V.L.D.L>40 mg/dl or/and
S.H.D.L <40 mg/dl
|
|
ExclusionCriteria |
Details |
• Age below 25 and above 60 years
• Patients suffering from type 1 Diabetes mellitus and uncontrolled diabetes mellitus & uncontrolled hypertension
• Drug induced & uncontrolled dyslipidemia
• Systemic illness like Tuberculosis, Carcinoma and Endocrine disorders
• Patient having the past history of M.I. & Unstable Angina.
• Patient having Clinical Features of CCF
• Patient Having the major renal or liver disorder
• Normal range of Apolipoprotien B is 40-125 mg/dl, if it increased with severity of symptoms, patients will be excluded.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Assessment will be made mainly based on the improvement observed in the subjective and objective parameters before treatment and after treatment. The prakriti, agnibala, roga bala and rogi bala will also be taken into consideration |
Assessment will be made mainly based on the improvement observed in the subjective and objective parameters before treatment and after treatment. The prakriti, agnibala, roga bala and rogi bala will also be taken into consideration |
|
Secondary Outcome
|
Outcome |
TimePoints |
assessment will be done by only symptoms. |
2 weeks |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
05/10/2013 |
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="2" 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)?
|
Brief Summary
|
Dyslipidemia is elevation of plasma cholesterol, triglycerides (TGs), or both, or a low high-density lipoprotein level that contributes to the development of atherosclerosis. Causes may be primary (genetic) or secondary. Diagnosis is by measuring plasma levels of total cholesterol, TGs, and individual lipoproteins. Treatment is dietary changes, exercise, and lipid-lowering drugs. There is no natural cutoff between normal and abnormal lipid levels because lipid measurements are continuous. A linear relation probably exists between lipid levels and cardiovascular risk, so many people with “normal†cholesterol levels benefit from achieving still lower levels. Consequently, there are no numeric definitions of dyslipidemia; the term is applied to lipid levels for which treatment has proven beneficial. Proof of benefit is strongest for lowering elevated low-density lipoprotein (LDL) levels. In the overall population, evidence is less strong for a benefit from lowering elevated TG and increasing low high-density lipoprotein (HDL) levels, in part because elevated TG and low HDL levels are more predictive of cardiovascular risk in women than in men. HDL levels do not always predict cardiovascular risk. For example, high HDL levels caused by some genetic disorders may not protect against cardiovascular disorders, and low HDL levels caused by some genetic disorders may not increase the risk of cardiovascular disorders. Although HDL levels predict cardiovascular risk in the overall population, the increased risk may be caused by other factors, such as accompanying lipid and metabolic abnormalities, rather than the HDL level itself. By seeing all conditions, we cannot find one to one co-relation with a single disease from Ayurveda classics, though condition is suggestive of pathologies like Rasagata Ama, Raktagata Ama, Sthaulya, Medoroga, Medodosha etc. By considering all the situations it can be assumed that of pathology is related to Kapha Karaka Nidana i.e.- Santarpana Ahara Vihara,which includes sedentary life style, high calories food intake, lack of exercise which finally leads to morbidity of Kapha Dosha and Medo Dhatu. Due to Medodhatwagni Dusti excessive accumulation of abnormal Kapha and Medo occurs in various Strotas in body. Aparipakva Kapha – Meda present in Rasa-Raktavaha Strotasa results in obstruction to the movement of Vata & Rakta through affected channel finally ends up in disease manifestation according to the site of affliction. The state of Apakva Kapha or Meda and its excessive presence Margavarana in Rasa-Raktavaha Strotasa is often compared with the state of dyslipidemia. Hence, a formulation named Tryoshnadiguggulu containing Ushna,Tikshna, Katu and Shrotoshodhaka action was selected for patients of dyslipidemia, it may help to break the Samprapti or Clear the Ama, Kapha,and Meda and hence may help to manage the dyslipidemia. Keeping in mind above facts, it may be said that The final purpose of management is to stop the formation of Apakva Kapha and Meda and to clear the avarana and then re-establishing the normal movement of vata. Recent work on Lasuna has showed lipid/cholesterol lowering effect and hence was also selected to establish its role in the management of dyslipidemia. |