A clinical trial to study effects of Rasapachaka Kashaya on overweight Prediabetic persons.

An open labeled randomized clinical trial to assess the efficacy of Rasapachaka Kashaya on overweight Prediabetic persons w.s.r. to Sthaulya. - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/066621

Enrollment

118

Registered

2024-05-01

Start date

Unknown

Completion date

Unknown

Last updated

2024-05-27

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

Conditions

Health Condition 1: R730- Abnormal glucose

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with FPG:100-125mg/dL and HbA1c: 5.7-6.4% without any medication. 2. Age group 30-60 yrs. 3. Patients will be selected irrespective of their sex, religion, geographical areas and economical condition.

Exclusion criteria

Exclusion criteria: 1. Patients with history of other diseases leading to DM (Autoimmune, Secondary to other diseases or condition). 2.Pregnant and lactating women. 3.Other major systemic disorders with complication. 4. Patients on steroidal intake for any other major systemic diseases.

Design outcomes

Primary

Measure	Time frame
Changes in the insulin resistance (HOMA-IR) value to be calculated with fasting glucose(mg/dl) ,fasting insulin levels(mu/L) and the HbA1c(%) values.Timepoint: 0 and 91st days for objective criterias.	—

Secondary

Measure	Time frame
1. To assess effect of Rasapachaka Kashaya on Fasting Plasma Glucose, HbA1c. 2. To assess the effect of Rasapachaka Kashaya on Insulin Resistance (Calculated with HOMA IR) 3. To study role of Rasapachaka Kashaya on Daurbalya, Atikshudha, Atitrushna. 4. To asses side effects of drug if any. 5. To assess the effect of Rasapachaka Kashaya in comparison with Rukshaniya Dravya Churna (3gm each with Koshna Jala)Timepoint: Fasting Plasma Glucose, HbA1c, Insulin Resistance (HOMA IR) on 0 and 91st days. Daurbalya, Atikshudha, Atitrushna on 0, 30, 60, 91st days and follow up assessment on 150 days.	—

Measure

Time frame

1. To assess effect of Rasapachaka Kashaya on Fasting Plasma Glucose, HbA1c. 2. To assess the effect of Rasapachaka Kashaya on Insulin Resistance (Calculated with HOMA IR) 3. To study role of Rasapachaka Kashaya on Daurbalya, Atikshudha, Atitrushna. 4. To asses side effects of drug if any. 5. To assess the effect of Rasapachaka Kashaya in comparison with Rukshaniya Dravya Churna (3gm each with Koshna Jala)Timepoint: Fasting Plasma Glucose, HbA1c, Insulin Resistance (HOMA IR) on 0 and 91st days. Daurbalya, Atikshudha, Atitrushna on 0, 30, 60, 91st days and follow up assessment on 150 days.

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Countries

India

Contacts

Public ContactDr V E Gogate

Govt. Ayurved College, Nanded

vgogate21@gmail.com9422214311

Outcome results