| CTRI Number |
CTRI/2024/07/070691 [Registered on: 16/07/2024] Trial Registered Prospectively |
| Last Modified On: |
13/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Trial to study the effect of Vatsakadi Vati in management of dyslipdemia |
|
Scientific Title of Study
|
A randomized controlled clinical study to see the efficacy of Vatsakadi 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 |
Dr Ajay Bhavsing Marmat |
| Designation |
PG scholar |
| Affiliation |
R.A.Podar Ayurvedic college |
| Address |
OPD no. 18/19, Kayachikitsa Department,R.A.Podar Ayurvedic college, Dr. Annie Besant road, worli, Mumbai
Mumbai MAHARASHTRA 400018 India |
| Phone |
8788947698 |
| Fax |
|
| Email |
ajaybhmarmat@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Geeta Parulkar |
| Designation |
HOD and Professor(Kayachikitsa),R.A.Podar medical college(Govt),worli,Mumbai-18 |
| Affiliation |
R.A.Podar Ayurvedic college |
| Address |
OPD no.18/19 Kayachiktsa Department,R.A.Podar Ayurvedic college, Dr. Annie Besant road, worli, Mumbai-18.
Mumbai MAHARASHTRA 400018 India |
| Phone |
8087101471 |
| Fax |
|
| Email |
geeta.parulkar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Geeta Parulkar |
| Designation |
HOD and Professor(Kayachikitsa),R.A.Podar medical college(Govt),worli,Mumbai-18 |
| Affiliation |
R.A.Podar Ayurvedic college |
| Address |
OPD no.18/19 Kayachikitsa Department,R.A.Podar Ayurvedic college, Dr. Annie Besant road, worli, Mumbai
Mumbai MAHARASHTRA 400018 India |
| Phone |
8087101471 |
| Fax |
|
| Email |
geeta.parulkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| M.A.Podar Ayurvedic Hospital, Dr. Annie Besant road, Worli,Mumbai-400018,Maharashtra,India. |
|
|
Primary Sponsor
|
| Name |
RAPodar Ayurvedic college |
| Address |
OPD no.18/19 R.A.Podar Ayurvedic college, Dr. Annie Besant road, worli, Mumbai |
| Type of Sponsor |
Government medical college |
|
|
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 Ajay Bhavsing Marmat |
M.A.Podar Ayurvedic Hospital |
OPD-18/19, Kayachikitsa department, Dr. Annie Besant road, worli, Mumbai 400018 Mumbai MAHARASHTRA |
8788947698
ajaybhmarmat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS committee of institution, R.A.Podar medical college (AYU) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E785||Hyperlipidemia, unspecified. Ayurveda Condition: MEDOVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | tab atorvastatin | tablet atorvastatin 10mg will be given to group B at night once a day for 8 weeks | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Vatsakadi vati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: warm water), Additional Information: It contains vatsak(Holarrhoea antidycenterica), Maricha (Piper nigrum), Guggulu (commiphora mukul) |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Both Genders.
2) Age group having 30 to 70 years age.
3)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).
4)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 |
|
| ExclusionCriteria |
| Details |
1)Pregnant and lactating mothers.
2)Patients having Diabetes Mellitus.
3)Patients having history of Respiratory Diseases Complications, Coronary Heart Diseases, Renal
Diseases etc.
4)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.
5)Patients having disorders like Carcinoma anywhere in the body etc. |
|
|
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 "vatsakadi vati" on lipid levels in medodushti w.s.r. to dyslipidaemia |
8 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe the effect on following Parameters
lipid profile
1.Total Cholesterol
2.VLDL
3.HDL
4.SR.TRIGLYSERIDES
5.LDL |
EVERY MONTHLY FOR 3 MONTHS |
|
|
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)
|
23/08/2024 |
| 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
|
|
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. |