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To study the effect of the drug Nishakatakadi Kashaya in Individuals with Prediabetes (Prameha Purvarupa)

Clinical evaluation of Nisha Katakadi Kashaya in Prameha Purvarupa: A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/099586
Enrollment
80
Registered
2025-12-22
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Health Condition 1: E70-E88- Metabolic disorders

Interventions

None listed

Sponsors

All India Institute of Ayurveda, Goa
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age between 30 to 60 years Presence of Purvarupa of Prameha As per diagnostic tool Diagnosed with prediabetes as per ADA criteria, fulfilling any one or more of the following Fasting Blood Sugar (FBS): 100 to 125 mg per dL Postprandial Blood Sugar (PPBS): 140 to 199 mg per dL HbA1c 5.7 to 6.4 Written informed consent provided Available for follow-up over 12 weeks

Exclusion criteria

Exclusion criteria: Diagnosed case of Type 2 Diabetes Mellitus (FBS greater than and equal to 126 mg/dL, PPBS greater than and equal to 200 mg/dL, or HbA1c greater than and equal to 6.5) Currently on oral hypoglycemic agents, insulin, or Ayurvedic antidiabetic medications Pregnant or lactating women Presence of major systemic illness (cardiac, renal, hepatic, or malignancy) Any condition likely to interfere with study compliance, such as psychiatric illness or substance abuse

Design outcomes

Primary

MeasureTime frame
The primary outcome of this study is the compilation of Prameha Purvarupa from all Samhitas & according to PRISMA guidelines. There is a difference in the Prameha Purvarupa assessment parameter grading from baseline to the end of the 12-week intervention period in both groups. Timepoint: Prameha purvarupa assessment parameter with grading scale at baseline, 4th week, 8th week and 12th week

Secondary

MeasureTime frame
The secondary outcome is the change in fasting blood sugar (FBS), postprandial blood sugar (PPBS), HbA1c level, and fasting insulin level from baseline to the end of the 12 weeks in both groups.Timepoint: Fasting Blood Sugar and Postprandial Blood Sugar at Baseline, 4th week, 8th week and 12th week; HbA1c level and Fasting Insulin Level at Baseline and at 12th week

Countries

India

Contacts

Public ContactProf Dr Mohan Joshi

All India Institute of Ayurveda Goa

manvantar@gmail.com9822435536

Outcome results

None listed

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