A prospective open labelled,single arm,non-randomized,single centric,phase II clinical trial to determine the effectiveness of Dhadimathi Kashayam in the management of Raththa Piththam(Systemic Hypertension)
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
Study Overview
Brief Summary
This is a prospective open labelled,single arm, non- randomized ,single centric, phase II clinical trial to determine the effectiveness of Dhadimathi kashayam in the management of Raththa Piththam (Systemic Hypertension ).The trial drug Dhadimathi kashayam is freshly prepared and will be administered at a dosage of 50ml (twice a daily before food )for 48 days for 40 known primary hypertension (20 OP and 20 IP patients ).The primary outcome will be determine the clinical efficacy of Dhadimathi kashayam (internal) in the management of Raththa Piththam (Systemic hypertension) .The secondary outcome will be collect the various siddha literatures and modern journals for literature review on Raththa Piththam.To study other cofactors related to disease like age,sex,dietary habits,family history and socioeconomic status .To perform physiochemical,phytochemical ,biochemical analysis of Dhadimathi Kashayam .To evaluate the safety profile for acute toxicity for Dhadimathi Kashayam .To evaluate pharmacological activities of Dhadhimathi Kashayam
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 35.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Known Systemic Hypertension High Normal (SBP 130-139 mmHg and/or DBP 85-89 mmHg) Grade 1 Hypertension (SBP 140-159 mmHg and/or DBP 90-99 mmHg) Grade 2 Hypertension (SBP 160-179 mmHg and/or DBP 100-109 mmHg).
Exclusion Criteria
- •Known Malignant hypertension Ischemic heart diseases Chronic kidney disease Chronic liver disease Malignancy Hyperlipidemia Diabetes mellitus Smoking and Alcoholism.
Investigators
DR RAM KUMAR M
Government Siddha Medical College and Hospital .