A Study to See if a Herbal Medicine Can Help People with Pre-Diabetes and Diabetes Manage Their Blood Sugar

An Open-label, Multi-arm, Single-center Clinical Study to Evaluate the Safety and Efficacy of Polyherbal Extract as an Adjuvant Therapy in Subjects with Pre-diabetic, Moderately-diabetic, and Severely-diabetic Conditions. - Nil

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/10/096623

Enrollment

Registered

2025-10-29

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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 Health Condition 2: E119- Type 2 diabetes mellitus without complications Health Condition 3: E11- Type 2 diabetes mellitus

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age between thirty and seventy-five years, of either gender. 2. Able and willing to provide written informed consent. For subjects aged sixty years and above, audio-visual consent is mandatory as per regulatory requirements. 3. Diagnosed as: 3.1 Prediabetic (HbA1c between five point seven percent and six point four percent) 3.2 Moderately diabetic (HbA1c greater than or equal to six point five percent) 3.3 Severely diabetic (HbA1c greater than or equal to eight point zero percent) 4. Stable on current diabetes medication for the past four weeks, if applicable. 5. Willing to comply with study procedures and visit schedule.

Exclusion criteria

Exclusion criteria: 1. Diagnosis of any major systemic illness, including: 1.1 Malignancies 1.2 Chronic obstructive pulmonary disease (COPD) 1.3 Hepatobiliary disease 1.4 Severe cardiovascular disorders 1.5 Blood disorders 2. Known hyperlipidemia, hepatic dysfunction, renal dysfunction, or uncontrolled pulmonary dysfunction. 3. Poorly controlled hypertension. 4. Participation in any other clinical trial within the last three months. 5. Pregnant or lactating women. 6. Known allergy or intolerance to any component of the investigational product. 7. Unwillingness or inability to comply with study procedures or to sign informed consent. 8. Any condition that, in the investigator s opinion, would interfere with study compliance or data interpretation.

Design outcomes

Primary

Measure	Time frame
1. Change in Glycosylated Hemoglobin (HbA1c) o Measured from baseline (Visit 4) to Day 90 (Visit 7) o Assesses long-term glycemic control over the 3-month treatment period 2. Change in Random Blood Sugar (RBS) - Evaluated from baseline to the end of the study using both: - Laboratory-based RBS measurements (Visits 1, 2, 3) - Weekly glucometer readings (pre- and post-breakfast) recorded in subject diaries Statistical Methods: - Within-group comparisons: Paired t-test or Wilcoxon signed-rank test - Between-group comparisons: ANOVA (parametric) or Kruskal-Wallis test (nonparametric), followed by post hoc tests if significant. - Effect Size: Mean SD, 95% confidence intervals.Timepoint: Screening Day -3, Day -2 and Day -1 Randomization/Baseline Day 0 Day 30 2 Days, Day 60 2 Days, Day 90 2 Days, Day 105 2 Days.	—

Measure

Time frame

1. Change in Glycosylated Hemoglobin (HbA1c) o Measured from baseline (Visit 4) to Day 90 (Visit 7) o Assesses long-term glycemic control over the 3-month treatment period 2. Change in Random Blood Sugar (RBS) - Evaluated from baseline to the end of the study using both: - Laboratory-based RBS measurements (Visits 1, 2, 3) - Weekly glucometer readings (pre- and post-breakfast) recorded in subject diaries Statistical Methods: - Within-group comparisons: Paired t-test or Wilcoxon signed-rank test - Between-group comparisons: ANOVA (parametric) or Kruskal-Wallis test (nonparametric), followed by post hoc tests if significant. - Effect Size: Mean SD, 95% confidence intervals.Timepoint: Screening Day -3, Day -2 and Day -1 Randomization/Baseline Day 0 Day 30 2 Days, Day 60 2 Days, Day 90 2 Days, Day 105 2 Days.

—

Secondary

Measure	Time frame
1. Change in SF-36 Quality of Life scores 2. Descriptive analysis of improvement in physical and mental health domains 3. Compliance Rate (% sachets taken out of total dispensed)Timepoint: Screening Day -3, Day -2 and Day -1 Randomization/Baseline Day 0 Day 30 2 Days, Day 60 2 Days, Day 90 2 Days, Day 105 2 Days.	—

Countries

India

Contacts

Public ContactMs Arpita Malgi

Samahitha Research Solutions

satyalm@samahitha.com09739001749

Outcome results