Effect of Virechana (a Panchakarma treatment) followed by oral administration of Nisha Amalaki Yoga in prediabetes

An Open Labelled Randomised Comparative Clinical study to Evaluate the efficacy of Virechana (Medicated Purgation) and Nisha Amalaki Yoga in the management of Prediabetes - NIL

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/067448

Enrollment

Registered

2024-05-15

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

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: Patients of pre-diabetes diagnosis according to American Diabetes Association (HbA1C - 5.7 to 6.4 %). Patients eligible for Virechana. Patients willing to sign informed consent and able to participate in the study procedure.

Exclusion criteria

Exclusion criteria: Known cases of Diabetes Mellitus, Insulin Dependent Diabetes, Juvenile Diabetes Mellitus And Gestational Diabetes. Known cases of Major Systemic Diseases like IHD, Malignancies, Uncontrolled Hypertension. Patients on prolonged medication (more than 6weeks) with Corticosteroids or any other Drug that may have an influence on the outcome of the study. Pregnant and lactating women. Patients with active infective diseases like Tuberculosis, Hepatitis B. Immunocompromised patients.

Design outcomes

Primary

Measure	Time frame
To compare the effect of Virechana followed by Nisha Amalaki Yoga & Nisha Amalaki Yoga alone in patients on the basis of HbA1C,Lipid Profile,Fasting and post prandial blood sugar level in patients of Prediabetes.Timepoint: HbA1C-On Screening Visit and 90th Day. Lipid Profile-On Screening Visit,After Virechana Karma and 90th Day. FBS-On Screening Visit,After Virechana Karma,30th Day,60th Day and 90th Day. PP2BS-On Screening Visit,After Virechana Karma,30th Day,60th Day and 90th Day.	—

Measure

Time frame

To compare the effect of Virechana followed by Nisha Amalaki Yoga & Nisha Amalaki Yoga alone in patients on the basis of HbA1C,Lipid Profile,Fasting and post prandial blood sugar level in patients of Prediabetes.Timepoint: HbA1C-On Screening Visit and 90th Day. Lipid Profile-On Screening Visit,After Virechana Karma and 90th Day. FBS-On Screening Visit,After Virechana Karma,30th Day,60th Day and 90th Day. PP2BS-On Screening Visit,After Virechana Karma,30th Day,60th Day and 90th Day.

—

Secondary

Measure	Time frame
To compare the effect of Virechana followed by Nisha Amalaki Yoga and Nisha Amalaki Yoga alone in patients on the basis of BMI,Body composition parameters and other subjective parameters in patients of Prediabetes.Timepoint: On Screening Visit,After Virechana Karma,15th Day,30th Day,45th Day,60th Day,75th Day and 90th Day.;To study the safety of Virechana and Nisha Amalaki Yoga in patients of Prediabetes.Timepoint: On Screening Visit,After Virechana Karma,15th Day,30th Day,45th Day,60th Day,75th Day and 90th Day.	—

Measure

Time frame

To compare the effect of Virechana followed by Nisha Amalaki Yoga and Nisha Amalaki Yoga alone in patients on the basis of BMI,Body composition parameters and other subjective parameters in patients of Prediabetes.Timepoint: On Screening Visit,After Virechana Karma,15th Day,30th Day,45th Day,60th Day,75th Day and 90th Day.;To study the safety of Virechana and Nisha Amalaki Yoga in patients of Prediabetes.Timepoint: On Screening Visit,After Virechana Karma,15th Day,30th Day,45th Day,60th Day,75th Day and 90th Day.

—

Countries

India

Contacts

Public ContactDr Divya B

Parul Institute of Ayurved

dr.shaileshd@gmail.com9763104451

Outcome results