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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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