To evaluate the efficacy and safety of Diabetic Low Glycemic Load-Kit with standard care of therapy in patients with Type 2 diabetes mellitus.

Single Site, Open label, Randomized, Comparative, Parallel-group, Active controlled, Pilot clinical study to evaluate the efficacy and safety of Diabetic Low Glycemic Load-Kit manufactured by NutroActive Industries Pvt. Ltd. with standard care of therapy in patients with Type 2 diabetes mellitus. - DIA

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2023/02/049417

Enrollment

Registered

2023-02-02

Start date

Unknown

Completion date

Unknown

Last updated

2023-08-21

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

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Diabetic Low Glycemic Load kit: Composition: Diabetic Low Glycemic Load Atta Diabetic Low Glycemic Load Cookies Diabetic Low Glycemic Load Barfi Diabetic Low Glycemic Load Sugar Route

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subject who agrees for giving informed consent and provide signed and dated written IEC/IRB approved Informed Consent Form (ICF) prior to initiation of any study procedures. 2. Patients diagnosed to be suffering from Type 2 diabetes mellitus. 3. Patient must be COVID-19 negative.

Exclusion criteria

Exclusion criteria: 1. Subjects who are not able to or not willing to sign an IRB/IEC approved consent form. 2. Patients with past 30 days history A) Any major illness that required hospitalization. B) Acute exacerbation of any ongoing chronic medical illness e.g.(Congestive cardiac failure Hepatitis, Hypotensive episodes HIV etc), Medications requiring change of doses for treatment of the chronic illness. 3. Patients suffering from severe cardiac renal liver or any other organ impairment. 4. Patient with any history of food allergy or any ingredient of investigational product. 5. Pregnant or lactating females. 6. Patients currently participating in any other clinical study.

Design outcomes

Primary

Measure	Time frame
The main outcome used to determine the effects of the intervention by measuring the following parameters: 1. Change in insulin resistance from base line to week 5 and week 12 (EOT). 2. Change in HbA1c from base line to Week 12 (EOT). 3. Change in fasting and Postprandial glucose level from baseline to week 2, week 5, week 8 and week 12 (EOT).Timepoint: Change in insulin resistance from base line to week 5 and week 12 (EOT). Change in HbA1c from base line to Week 12 (EOT). Change in fasting and Postprandial glucose level from baseline to week 2, week 5, week 8 and week 12 (EOT).	—

Measure

Time frame

The main outcome used to determine the effects of the intervention by measuring the following parameters: 1. Change in insulin resistance from base line to week 5 and week 12 (EOT). 2. Change in HbA1c from base line to Week 12 (EOT). 3. Change in fasting and Postprandial glucose level from baseline to week 2, week 5, week 8 and week 12 (EOT).Timepoint: Change in insulin resistance from base line to week 5 and week 12 (EOT). Change in HbA1c from base line to Week 12 (EOT). Change in fasting and Postprandial glucose level from baseline to week 2, week 5, week 8 and week 12 (EOT).

—

Secondary

Measure	Time frame
To evaluate Overall improvement in Quality of Life as assessed by Quality of Life Questionnaire.Timepoint: Visit 1, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7.	—

Countries

India

Contacts

Public ContactMukesh Kumar

Rahe life Science

mukesh@rahelife.com9873038019

Outcome results

None listed

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