Clinical Trial to evaluate the effects of Dibosudha tablet and Diabosudha Liquid Diabetes Mellitus type 2.

Phase 3

Suspended

• Conditions: Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH,

• Registration Number: CTRI/2022/11/047116
• Lead Sponsor: Sahyadri Ayurvedic Life Pvt. Ltd.

Brief Summary

The study is designed as an Open Label,Single arm, prospective, Clinical study to evaluate efficacy and safety ofDiabosudha Tablet and Diabosudha Liquid in Subjects with Mild to ModerateDiabetes Mellites Type 2.

All the subjects will receive DIBOSUDHATablet and Liquid as a test product. Subjects fulfilling the inclusion andexclusion criteria will be enrolled in the study. Enrolled subjects will beunder treatment for 12 weeks.

The study will include 2 periods for a totalof up to 13 weeks:

1.     Screening Period: There will be a period upto 1 week for subject screening, based on medical history, physical examinationand clinical laboratory investigations and meeting all inclusion and exclusioncriteria.

After signing the informed consent, subjects will undergo screeningprocedures and Assessment.

2.     Baseline: Safety parameters like hematology and biochemistrywill be assessed at baseline and at week 12.

 3.     Treatment period (12 weeks):Thetreatment period will consist of 12 weeks of treatment with study medication,starting on Day 0. Treatment visits will occur at Weeks 4, 8 and 12 of thetreatment period. HbA1c will be measured at End-of- Treatment/Early Terminationvisit (Week 12) and BSL will be measured at every visit.

Subjects who meet protocol discontinuation criteria will be asked toreturn to the clinic for follow-up assessment and confirmation of values priorto discontinuation.

Discontinued subjects must complete Early Termination Visit procedures.

The study is designed as an Open Label,Single arm, prospective, Clinical study to evaluate efficacy and safety ofDiabosudha Tablet and Diabosudha Liquid in Subjects with Mild to ModerateDiabetes Mellites Type 2.

All the subjects will receive DIBOSUDHATablet and Liquid as a test product. Subjects fulfilling the inclusion andexclusion criteria will be enrolled in the study. Enrolled subjects will beunder treatment for 12 weeks.

The study will include 2 periods for a totalof up to 13 weeks:

1.     Screening Period: There will be a period upto 1 week for subject screening, based on medical history, physical examinationand clinical laboratory investigations and meeting all inclusion and exclusioncriteria.

After signing the informed consent, subjects will undergo screeningprocedures and Assessment.

2.     Baseline: Safety parameters like hematology and biochemistrywill be assessed at baseline and at week 12.

 3.     Treatment period (12 weeks):Thetreatment period will consist of 12 weeks of treatment with study medication,starting on Day 0. Treatment visits will occur at Weeks 4, 8 and 12 of thetreatment period. HbA1c will be measured at End-of- Treatment/Early Terminationvisit (Week 12) and BSL will be measured at every visit.

Subjects who meet protocol discontinuation criteria will be asked toreturn to the clinic for follow-up assessment and confirmation of values priorto discontinuation.

Discontinued subjects must complete Early Termination Visit procedures.

AE/SAEwill be recorded during the conduct of the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-11
• Last Update Posted: 2024-09-08

Recruitment & Eligibility

• Status: Suspended
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

• Gender: Either male or non-pregnant, non-lactating female aged > 18-70 < years (both inclusive).
• Type 2 diabetes subjects (diagnosed clinically) ≥ 6 months prior to screening.
• HbA1c ≥ 7.0 % and ≤ 10.0 % (both inclusive).
• Subjects willing to give written informed consent.
• Subjects able to comply with the study protocol.
• Women of child bearing potential must have a negative urine pregnancy test prior to study entry.
• Are willing to avoid participation in any other interventional clinical trial for the duration of this study.

Exclusion Criteria

• Suspected or confirmed pregnancy.
• Diagnosis of any known chronic or acute medical disease of any kind (e.g., cardiovascular disease, respiratory disease, influenza, pneumonia, etc.) 3.
• Diagnosis of any known neurological disease or psychological disorder of any kind (e.g., brain lesion, epilepsy, anxiety, eating disorder, mood disorder, sleep disorder, etc.) 4.
• Any implanted electrical medical device (e.g., pacemaker, insulin pump, deep brain stimulator, etc.) 5.
• Any form of prescription medication.
• Use of antibiotics in the three months prior to enrolment.
• A direct or familiar relationship with the Sponsor, Investigator, or site personnel affiliated with the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Change in level of HbA1c from baseline	Day 0 To Day 90

Secondary Outcome Measures

Name	Time	Method
•Change in lipid panel test values	Day 0 To Day 90
•Change in patient reported outcome for weight increase/ decrease, hunger and thirst and frequent urination at various follow up appointments	Day 0 To Day 90
•Change in BSL values	Day 0 To Day 90

Trial Locations

Locations (1)

Datta Meghe Ayurvedic medical College Hospital and Research Center; 🇮🇳 Nagpur, MAHARASHTRA, India

Datta Meghe Ayurvedic medical College Hospital and Research Center

🇮🇳Nagpur, MAHARASHTRA, India

Dr Harshala Rajurkar Sharma

Principal investigator

9067317029

harshalasharma@gmail.com