| CTRI Number |
CTRI/2024/06/069018 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
08/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Trial to assess the effect of Varunadi Vati in Medodushti w.s.r. to Dyslipidemia |
|
Scientific Title of Study
|
A Randomized controlled clinical study to assess the effect Of Varunadi Vati in management of Medodushti with special reference to Dyslipidemia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akanksha Vijay Agale |
| Designation |
MD (Final Year), Kayachikitsa |
| Affiliation |
R. A. Podar Medical College (Govt.) (Ayu) |
| Address |
Kayachikitsa Department, R. A. Podar Medical College (Govt.) (Ayu), Dr. Annie Besant Road, Worli, Mumbai-400018
Mumbai MAHARASHTRA 400018 India |
| Phone |
8999095030 |
| Fax |
|
| Email |
akankshaagale09@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Geeta Deodatt Parulkar |
| Designation |
HOD & Professor (Kayachikitsa) |
| Affiliation |
R. A. Podar Medical College (Govt.) (Ayu) |
| Address |
OPD No. 19, Kayachikitsa Department, R. A. Podar Medical College (Govt.) (Ayu), Dr. Annie Besant Road, Worli, Mumbai-400018
Mumbai MAHARASHTRA 400018 India |
| Phone |
08652694332 |
| Fax |
|
| Email |
geeta.parulkar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Akanksha Vijay Agale |
| Designation |
MD (Final Year), Kayachikitsa |
| Affiliation |
R. A. Podar Medical College (Govt.) (Ayu) |
| Address |
Kayachikitsa Department, R. A. Podar Medical College (Govt.) (Ayu), Dr. Annie Besant Road, Worli, Mumbai-400018
MAHARASHTRA 400018 India |
| Phone |
8999095030 |
| Fax |
|
| Email |
akankshaagale09@gmail.com |
|
|
Source of Monetary or Material Support
|
| M. A. Podar Ayu Govt Hospital, Worli, Mumbai-18 |
|
|
Primary Sponsor
|
| Name |
M A Podar Ayurvedic Hospital Dr Annie Besant Road Worli Mumbai |
| Address |
OPD No. 19, Kayachikitsa Department, R. A. Podar Medical College (Govt.) (Ayu), Dr. Annie Besant Road, Worli, Mumbai-400018 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Akanksha Agale |
M. A. Podar Ayu Hospital, Worli, Mumbai-18 |
OPD No. 19,Kayachikitsa Mumbai MAHARASHTRA |
08999095030
akankshaagale09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS Comnittee of Institution, R. A. Podar Medical College (Ayu.) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E785||Hyperlipidemia, unspecified. Ayurveda Condition: MEDOVAHASROTODUSHTIH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Atorvastatin | Control Group- 10 mg at Bed time for 8 weeks | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Varunadi Vati, Reference: NA, Route: Oral, Dosage Form: Guggulu, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: -Swanubhut Yoga
Varuna- 1 part
Haritaki- 1 part
Guggulu- 2 parts |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
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
Patient having Serum LDL Cholesterol Level ≥130mg/dl
Patient having serum VLDL Cholesterol Level ≥40 mg/dl
Patient having Serum HDL Cholesterol Level ≤40mg/dl
Patient having Serum Triglyceride Level ≥150mg/dl |
|
| ExclusionCriteria |
| Details |
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. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of “Varunadi Vati†on Lipid Levels (Lipid Profile) in Dyslipidemia. |
8 weeks
Follow up: Screening of patients clinically every week and Lipid Profile repeated every month (i.e every 4 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe the effect of ‘Varunadi Vati’ in comparison with Tab. Atorvastatin on Lipid Profile in patients of Dyslipidemia over a period of 8 weeks.
|
8 weeks
Follow up: Screening of patients clinically every week & Lipid Profile repeated every month (i.e every 4 weeks) |
|
|
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 3 |
|
Date of First Enrollment (India)
|
19/06/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
The main aim of Ayurveda is to cure the diseases and maintain health state. Ayurveda aims in maintaining and restoring body’s own capacity to have balance and fight with ailments. In today’s era, excessive intake of food along with stress, lack of exercise, and frequent consumption of junk food, canned food, soft drinks, beverages, food containing high amount of fat and calories leads to Coronary Artery Disease [1] making lipid disorders as one of the most common disorders of present era. In our body there are many tissues which are rich in lipids such as Medo Dhatu, Vasa and Majja Dhatu. Among the above lipids, Medo Dhatu is very important as it has a significant role in developing many metabolic diseases.[2] Dyslipidemia involves abnormality in levels of any or all lipoproteins in the blood. It can be co-related to “Medodushti†as described in Ayurveda. [3] High fatty diet (Snighdha, Guru, Pichhila) and sedentary lifestyle (Cheshtadvesha, Asana-sukha) may contribute to Dyslipidemia. This is described as “Medodushtiâ€. This condition is associated with several morbid manifestations. Dyslipidemia is highly prevalent and is one of the most modifiable risk factors for Cardiovascular disease. Worldwide, Cardiovascular disease is now one of the most common causes of death. [3] High cholesterol levels are estimated to cause 18% of stroke, and 56% of Ischemic Heart Disease that accounted to 4.4 million deaths, annually worldwide. Rigorous support is provided by the prospective, community-based Framingham Heart study for the concept that Hypercholesterolemia and other factors correlated with Cardiovascular risk. (4) Dyslipidemia is an elevation of Plasma Cholesterol, Triglycerides or both or a Low/ High Density Lipoprotein Level that contributes to the development of Atherosclerosis. For early development of Cardiovascular diseases; risk factors are Hypertension, Atherosclerosis, Dyslipidemia, Chronic inflammation etc. 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. [3] We can correlate Dyslipidemia with “Medodushtiâ€. According to Acharya Charaka, major/daily intake of causative factors aggravate Kapha Dosha and Meda Dhatu due to similar properties, thus increases Meda, which obstructs the Strotasas and hence obstructed Vata circulates in the Koshtha becomes hyperactive leads to Jatharagni Vruddhi.[6] Vruddha Jatharagni digests the food rapidly. If a person requires the food frequently or in high quantity, it increases Vata as well as Jatharagni on unavailability of food tends to severe complications. Jatharagni plays a very important role in growth, development and maintenance of the body. If it is impaired, the Bhutagni and Dhatvagnis (related to Liver and Cellular metabolism), especially impaired Medodhatvagni resulting in homologous nutrients i. e excess Poshak Meda Dhatu in circulation ultimately develops Dyslipidemia. The Ayurvedic methods of lifestyle modification and Apatarpanajanya Ahara prevent Dyslipidemia and provide better management over Allopathic drugs burden. Prevalence of Dyslipidemia according to NCEP (National Cholesterol Education Programme) is very high with 79% of subjects having at least one lipid abnormality.[5] In the first phase of ICMR INDIAB study [4] the prevalence was 13.9% in Hypercholesterolemia, 29.5% in high TG, 72.3% in low HDL-C and 11.8% in high LDL-C. According to Recent trends in epidemiology of Dyslipidemia in India (Indian Heart Journal 2017), total cholesterol ≥200 mg/dl was present in 25–30% in urban and 15–20% in rural subjects. The increase of Prevalence of Hypercholesterolemia and Hypertriglyceridemia is more prominent in 31-40 years age group than in ≤30 years age group.[4] The National Cholesterol Education Program Expert Panel (NCEP) on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) reinforced LDL as the Primary target of Cholesterol- lowering therapy with the optimal goal of its level below 100 mg/dL. ‘Statins’ are usually Recommended as they reduce LDL cholesterol by up to 60% and produce small increase in HDL and modest decrease in TGs. [4] 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 for high LDL Cholesterol, Low HDL Cholesterol and Triglycerides. Studies have reported that over 20 years of period, Total Cholesterol, LDL and Triglycerides have increased among Urban population. [4]
The contents of “Varunadi Vati†are Varuna (Crataeva nurvala), Haritaki (Terminalia chebula) and (Purana & Shuddha) Guggulu. (Commiphora mukul), which are described in Ashtangsamgraha’s Vividhganasangraha Adhyaya of Sutrasthana. Katu Rasa of Varuna and Haritaki, as well as (Purana and Shuddha) Guggulu will increase the activities of Kleda-Shoshana and Lekhana with the help of their particular characteristics [7]. Because of Tikta Rasa of Varuna, Haritaki and (Purana and Shuddha) Guggulu, this Kalpa can achieve Kledaharana, Medoshoshana, Deepana-Pachana and Kaphashamana [8] All this can be beneficial in Sampraptibhanga of “Medodushti†(Dyslipidemia). Additionally, ‘Predominant Katu Vipaka’ of Varuna and (Purana and Shuddha) Guggulu will play a role to reduce vitiated Kapha in the said disease with 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 disease by maintaining equilibrium of Tridoshas in the body as per ‘Rasayana Principle’. The most precious quality of (Purana and Shuddha) Guggulu is, it is the most ‘Shreshtha’ (Predominant) Dravya among Meda-Vataharadravyas. It also acts as Tridoshahara(9 ,10] and Lekhaniya Dravya[11] After observation of previous research on all above said properties of this Varunadi Vati, we can say that it will definitely lead to expected Sampraptibhanga (breaking of Pathophysiology) in “Medodushti†(Dyslipidemia). |