A Clinical trial on vaasathi kashayam in the management of raththa kothippu noi (Systemic hypertension)

A PROSPECTIVE OPEN LABELLED, SINGLE ARM, NON- RANDOMIZED, SINGLE CENTRIC, PHASE II CLINICAL TRIAL TO DETERMINE THE EFFECTIVENESS OF VAASATHI KASHAYAM IN THE MANAGEMENT OF RATHTHA KOTHIPPU NOI (SYSTEMIC HYPERTENSION)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/05/052414

Enrollment

Registered

2023-05-09

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Health Condition 1: I10- Essential (primary) hypertension

Interventions

Intervention1: VAASATHI KASHAYAM: DOSAGE: 30-60 ml FREQUENCY: Twice a day ROUTE OF ADMINISTRATION: orally ADJUVANT: Jaggery DURATION: 50 days Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 1.Known Systemic Hypertensive patients 2.Grade 2 Hypertension (SBP 160-179 mmHg and/or DBP 100-109 mmHg) 3.Patients willing to participate in the study.

Exclusion criteria

Exclusion criteria: 1.Age: Below 34 ; Above 66 2.Known Malignant hypertension 3.Ischemic heart diseases 4.Chronic kidney disease 5.Chronic liver disease 6.Secondary malignancy 7.Dyslipidemia 8.Diabetes mellitus Ã¢â?¬â?? Type II 9.Smoking and Alcoholism.

Design outcomes

Primary

Measure	Time frame
The outcome will be aimed at reducing systemic blood pressure. If during or after treatment, SBP less than or equal to 130mmHg and DBP less than or equal to 90mmHg, will be considered as successful outcome of the treatment.Timepoint: 50 days	—

Secondary

Measure	Time frame
1.To collect various Siddha literatures and modern journals for literature review on RATHTHA KOTHIPPU NOI. 2.To study other cofactors related to disease like age, sex, dietary habits, family history, and socioeconomic status. 3.To perform physicochemical, phytochemical, bio chemical analysis of VAASATHI KASHAYAM. 4.To evaluate safety profile for acute and sub-acute toxicity of -VAASATHI KASHAYAM. 5.To evaluate pharmacological activities of VAASATHI KASHAYAM. 6.To perform in-vitro, in-vivo studies. 7.To perform molecular docking studies on the trial drug in ACE inhibitor and Angiotensin receptor blocker activities. 8.To perform cell line studies for its anti-hypertensive activities. 9.To study about the prevalence of RATHTHA KOTHIPPU NOI in relation with diet and lifestyle. 10.To evaluate Siddha parameters (including Envagai thervu, Neerkuri-Neikuri) in RATHTHA KOTHIPPU NOI during trial period. 11.To evaluate modern parametric changes in RATHTHA KOTHIPPU NOI.Timepoint: 50 days	—

Measure

Time frame

1.To collect various Siddha literatures and modern journals for literature review on RATHTHA KOTHIPPU NOI. 2.To study other cofactors related to disease like age, sex, dietary habits, family history, and socioeconomic status. 3.To perform physicochemical, phytochemical, bio chemical analysis of VAASATHI KASHAYAM. 4.To evaluate safety profile for acute and sub-acute toxicity of -VAASATHI KASHAYAM. 5.To evaluate pharmacological activities of VAASATHI KASHAYAM. 6.To perform in-vitro, in-vivo studies. 7.To perform molecular docking studies on the trial drug in ACE inhibitor and Angiotensin receptor blocker activities. 8.To perform cell line studies for its anti-hypertensive activities. 9.To study about the prevalence of RATHTHA KOTHIPPU NOI in relation with diet and lifestyle. 10.To evaluate Siddha parameters (including Envagai thervu, Neerkuri-Neikuri) in RATHTHA KOTHIPPU NOI during trial period. 11.To evaluate modern parametric changes in RATHTHA KOTHIPPU NOI.Timepoint: 50 days

—

Countries

India

Contacts

Public ContactProfDrAManoharan

Government Siddha Medical College, Palayamkottai

drmanoharan25@gmail.com9443886700

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 27, 2026