| CTRI Number |
CTRI/2023/04/051904 [Registered on: 24/04/2023] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to evaluate the efficacy and safety of NATBERB as a add on therapy for Type 2 diabetes Mellitus |
|
Scientific Title of Study
|
An Open-labelled, Single Arm, Interventional Clinical Study to Evaluate the Efficacy and
Safety of NATBERB (100% Natural Berberine) as an adjuvant therapy in Type 2
Diabetes mellitus |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| TG/CLI/072, Version 2.0, Dated 25 May 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajendra Narayan Sharma |
| Designation |
Principal Investigator |
| Affiliation |
Trial Guna Pvt Ltd |
| Address |
TrialGuna Pvt Ltd.
#467, 1st Main, 4th Cross, Royal County Layout,
JP Nagar 8th Phase, 2nd Block, Bangalore
Bangalore
KARNATAKA
560083
India |
| Phone |
8867125414 |
| Fax |
|
| Email |
dr.r.n.sharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajendra Narayan Sharma |
| Designation |
Principal Investigator |
| Affiliation |
Trial Guna Pvt Ltd |
| Address |
TrialGuna Pvt Ltd.
#467, 1st Main, 4th Cross, Royal County Layout,
JP Nagar 8th Phase, 2nd Block, Bangalore
KARNATAKA
560083
India |
| Phone |
8867125414 |
| Fax |
|
| Email |
dr.r.n.sharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Meena Dalal |
| Designation |
CRO Representative |
| Affiliation |
Trial Guna Pvt Ltd |
| Address |
467, 1st Main Rd, Royal County, 8th Phase, Gottigere, Bengaluru, Karnataka
Bangalore
KARNATAKA
560083
India |
| Phone |
9972636265 |
| Fax |
|
| Email |
meena@trialguna.com |
|
|
Source of Monetary or Material Support
|
| Herbal Creations (A Unit of Kumaon Exports Pvt. Ltd.) |
|
|
Primary Sponsor
|
| Name |
Herbal Creations (A Unit of Kumaon Exports Pvt. Ltd.) |
| Address |
Vill: Nayagaon, Chandansingh, Block- Kotabagh
Distt: Nainital, Uttarakhand -263139 |
| Type of Sponsor |
Other [Manufacturer, Exporter and Supplier of Phytochemicals and Herbal Extracts] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajendra Narayan Sharma |
TrialGuna Private Limited |
#467, 2nd floor,1st Main Rd, Royal County, 8th Phase, Gottigere, Bengaluru, Karnataka
Bangalore
KARNATAKA |
8867125414
dr.r.n.sharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: berberine, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: 2 times after food |
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex between the age group 18 to 55 years(both inclusive).
2. Patients who are diagnosed as suffering from Type 2 Diabetes mellitus.
3. Patients with HbA1c ≥ 7.0%.
4. Subjects with Body Mass Index (BMI) >27 kg/m2 and<45 kg/m2.
|
|
| ExclusionCriteria |
| Details |
1.Type 1 diabetes mellitus
2.Patients with severe hyperglycemia (FBS >240 mg% or PPBS >360 mg%)
3.Patients with fasting serum cholesterol >260mg%
and serum Triglycerides>300 mg%.
4.Patients with HbA1c more than 10.5 %.
5.Patients with ASAT and ALT levels greater than 2.5 times the upper normal limits
6.Severe renal, hepatic or respiratory disorder. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate Changes in the diabetic panel, i.e., glycosylated hemoglobin (HbA1C), fasting
blood sugar and post prandial blood sugar.
|
Day 0, Day 1, Day 15, Day 30, Day 45 and Day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe the quality of life by evaluating the reduction in Body mass index (BMI) and
changes in lipid profile, TSH, Serum creatinine and bilirubin. |
Day 0, Day 1, Day 15, Day 30, Day 45 and Day 60. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "46"
Final Enrollment numbers achieved (India)="46" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
25/04/2023 |
| Date of Study Completion (India) |
30/01/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
An Open-labelled, Single Arm, Interventional Clinical Study to Evaluate
the Efficacy and Safety of NATBERB (100% Natural Berberine) as an
adjuvant therapy in Type 2 Diabetes mellitus.Treatment group: Subjects with Type 2 Diabetes Mellitus will
be administered with Berberine.Total of 30 subjects.Visit 1/Day 0- ICF and Screening procedures such as;
Hematological Investigations, Serological Investigations,
Urinalysis and UPT
ï‚· Visit 2/Day-1-Enrollment
ï‚· Visit 3/Day 15-, FBS, PPBS
ï‚· Visit 4/Day 30-FBS, PPBS
ï‚· Visit 5/Day 45- FBS PPBS
ï‚· Visit 6/Day 60 EOS In-person visit- repeat of all screening
procedures such as; Hematological Investigations, Serological
Investigations, Urinalysis and UPT |