A randomized controlled clinical study to see the efficacy of Vatsakadi Vati in management of Medodushti with special reference to Dyslipidemia.
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- To assess the effect of "vatsakadi vati" on lipid levels in medodushti w.s.r. to dyslipidaemia
Study Overview
Brief Summary
Dyslipidemia is a disorder of lipoprotein metabolism which includes abnormality in any or all the lipoprotein in blood. It may be manifested by elevation of the Total Serum Cholesterol, Low Density Lipoproteins (LDL) concentration, Triglyceride Cholesterol concentration and decreased in High Density Lipoproteins (HDL) Cholesterol concentration in blood. Cardiovascular diseases is a leading cause of mortality in many economically developed nations accounting near about 30% of all deaths. The co-existence of Hypertension and Dyslipidemia has adverse impact on vascular endothelium, which results in enhanced Atherogenesis leading to Cardiovascular and Cerebrovascular diseases.
The scattered references available in Ayurveda correlating Dyslipidemia, with Medodhatu. Abnormal composition of Medodhatu is considered as Medodushti Above described etiological factors influences and disturb the Jatharagni primarily and consequently Bhutagni and Dhatvagni, which results in ’Agnimandya’. It further disturbs the production of seven elements of body which we called as Saptadhatus. Hence, derangement of Jatharagni in general and Medodhatvagni in particular leads to excessive formation of Saam or Apachit Medodahtu, which finally results in Medodushti (Dyslipidemia). lipids can be correlated
Prevalence of Dyslipidemia according to NCEP (National Cholestrol Education Programme) is ver high with 79% of subjects having at least one lipid abnormality. Recent studies reported that high Cholesterol is present in 25-30 % in Urban & 15-20% in Rural population. The most common Dyslipidemia in India are borderline high LDL Cholesterol, Low HDL Cholesterol and Triglycerides. Studies have reported that over 20 years of period, Total Cholesterol, LDL Cholesterol ant Triglycerides have increased among Urban population.
The contents of Vatsak-Marich-Guggulu are Vatsak (Holarrhena Antidysenterica) and Marich(Piper nigrum) (clerodendron Serratum) and (Purana and Shuddha) Guggulu (Commiphora mukul ). The first two Dravyas are from vatsakadi gana (9)described in "Ashtangsangraha’s Vividhaganasagraha Adhyaya under Sutrasthan. Katu ras of vatsak, Marich and (Purana and Shuddha) Guggulu will increase the qualities of Kleda-Shoshana and Lekhana by the help of their particular characteristics. Additionally, Tikta Rasa of all the said contents also can help to achieve Kledaharana, Medoshoshana, Deepana-Pachana.
Predominant Katu Vipaka of vatsak, Marich and (Purana and Shuddha) Guggulu will play a role to reduce vitiated Kapha in the mentioned disease by the action of "Laghu Guna’. The most important feature of this Guggulu Kalpa is ’Rasayana quality so as to gain the resistance power against this Vyadhi by maintaining equilibrium of Tridoshas in the body as per ’Rasayana Principle’. The most precious quality of Guggulu is that, it is a ’Shreshtha’ (Predominant) Dravya among Meda-Vatahara Dravyas, It also acts as Tridoshahara
After observation of previous research on all above said properties of this Vatsak-Marich- Guggulu Vati, we can say that it will definitely lead to expected Sampraptibhanga (breaking of Pathophysiology) in Medodushti (Dyslipidemia).
During study, vatsakadi vati will be given to trial group (30 patients) and tab atorvastatin 10mg will be given to control group (30 patients) for 8 weeks
Investigation to be done-
1)Blood- CBC,ESR,Liver Function and Renal Function Tests before treatment as routine and to exclude complications said in ’Exclusion Criteria’.
2)Blood Sugar (Fasting and Post-Prandial) before treatment as routine and to avoid Diabetes Mellitus.
3)Lipid Profile before and after treatment (i.e. to be repeated after 4th and 8th week).
4)X-Ray (Chest) PA view before treatment as routine to avoid Respiratory disease complications.
5)ECG before treatment as routine to avoid Cardiac Diseases complications.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 30.00 Year(s) to 70.00 Year(s) (—)
Inclusion Criteria
- •Both Genders.
- •Age group having 30 to 70 years age.
- •Obese Dyslipidemic and Non-Obese Dyslipidemic Patients (BMI-18.50 to 40.00 kg/m2 as per New Updated WHO classification of BMI of 2004).
- •Patient having Serum Total Cholesterol Level ≥200mg/dl 5)Patient having Serum LDL Cholesterol Level ≥130mg/dl 6)Patient having serum VLDL Cholesterol Level ≥40 mg/dl 7)Patient having Serum HDL Cholesterol Level ≤40mg/dl 8)Patient having Serum Triglyceride Level ≥150mg/dl.
Exclusion Criteria
- •Pregnant and lactating mothers.
- •Patients having Diabetes Mellitus.
- •Patients having history of Respiratory Diseases Complications, Coronary Heart Diseases, Renal Diseases etc.
- •Patients having Acute Complications like Severe Hypertension (B.P 150/90 mm Hg in those with age 60 and older, and 140/90 mm Hg for adults less than 60 yrs.
- •according to Eighth Joint National Committee Guideline), Hepatitis or with history of major surgery etc.
- •Patients having disorders like Carcinoma anywhere in the body etc.
Outcomes
Primary Outcomes
To assess the effect of "vatsakadi vati" on lipid levels in medodushti w.s.r. to dyslipidaemia
Time Frame: 8 weeks
Secondary Outcomes
- To observe the effect on following Parameters(lipid profile)
Investigators
Dr Ajay Bhavsing Marmat
R.A.Podar Ayurvedic college