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Prevention and management of Metabolic syndrome by a plant based Ayurvedic formulation and prevention from coronary heart disease

A clinical trial on the Role of a Polyherbal Ayurvedic formulation in the prevention and management of metabolic syndrome

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/12/005276
Enrollment
1000
Registered
2014-12-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Metabolic syndrome

Interventions

Intervention1: The dried rhizome of Dioscorea bulbifera, Fruits of Hippophae rhamnoides, Fruits & Seeds of Terminalia chebula, Bark of Terminalia arjuna and Rhizome of Nardostachys jatamansi were util
Terminalia arjuna 75mg
Terminalia chebbula 100 mg
Hippophae rhamnoides 112.5 mg
Nardostachys jatamansi 62.5mg and additives: 25 mg (CaCO3)) was prepared. The drug was administered 1 capsule twice in day i.e. 1 capsule morning after breakfast (8 am) and 1 capsule evening after me

Sponsors

Dr Jeevan Sharma MD Ay
Lead Sponsor
Dr Aruna Agrawal PhD
Collaborator
Dr Jeevan Sharma
Collaborator
Dr K Srinath MD
Collaborator
Dr Satish Kumar Balian Md Ay
Collaborator
Dr Vijay Chaudhary
Collaborator
Prof BN Upadhyay MD Ay PhD
Collaborator
Prof KS Laxmi
Collaborator
Prof RG Singh MD DM Nephrology
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1.Triglycerides >150 mg% 2.Abdominal girth Male > 102 cm and Female > 85 cm 3.BP systolic > 130 mm Hg and Diastolic > 85 mm Hg 4.HDL 5.Fasting Blood Sugar > 100 mg%

Exclusion criteria

Exclusion criteria: 1. FBS 2. TG 3. BP Systolic

Design outcomes

Primary

MeasureTime frame
Prevention and management of metabolic syndrome by a novel Ayurvedic formulation was carried out and the therapeutic potential of test drug was established. Further the future occurrence of adverse cardiac event was assessed among selected cases.Timepoint: 5 Years

Secondary

MeasureTime frame
The Metabolic syndrome cases with insulin resistance were prevented from fulflaged manifestation of diabetes, prevented from Renal and cardiac invovlement. Reduction in obesity and hypertension following test formulation treatment in Metabolic syndrome patients prevented them from development of coronary heart disease and premature death as well.Timepoint: From baseline to 10 years

Countries

India

Contacts

Public ContactDr R G Singh

Institute of Medical Sceicnes

profrgsingh@yahoo.com05422369938

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026