| CTRI Number |
CTRI/2023/09/057969 [Registered on: 22/09/2023] Trial Registered Prospectively |
| Last Modified On: |
20/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
β-amyrin Palmitate with Activated Curcumin Complex combination versus Metformin in newly diagnosed patients of type 2 diabetes mellitus associated with dyslipidemia |
|
Scientific Title of Study
|
A randomized, double-blinded, double dummy, parallel, comparative study to evaluate the efficacy and safety of β-amyrin Palmitate with Activated Curcumin Complex combination versus Metformin in newly diagnosed patients of type 2 diabetes mellitus associated with dyslipidemia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Giriraja K V |
| Designation |
Principal Investigator |
| Affiliation |
Rajalakshmi Hospital |
| Address |
Department of General Medicine, Ground Floor, 21/1 Lakshmipura Main Road, Vidyaranyapura Post.
Bangalore
KARNATAKA
560097
India |
| Phone |
9448039952 |
| Fax |
|
| Email |
girirajakv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Satish G |
| Designation |
Vice President |
| Affiliation |
Sami Sabinsa Group Limited |
| Address |
19/1 & 19/2, I Main, II Phase, Peenya Industrial Area
Bangalore.
Bangalore
KARNATAKA
560058
India |
| Phone |
08068527777 |
| Fax |
|
| Email |
satish.g@clinworld.net |
|
Details of Contact Person
Public Query
|
| Name |
Satish G |
| Designation |
Vice President |
| Affiliation |
Sami Sabinsa Group Limited |
| Address |
19/1 & 19/2, I Main, II Phase, Peenya Industrial Area
Bangalore.
Bangalore
KARNATAKA
560058
India |
| Phone |
08068527777 |
| Fax |
|
| Email |
satish.g@clinworld.net |
|
|
Source of Monetary or Material Support
|
| Sami Sabinsa Group Limited |
|
|
Primary Sponsor
|
| Name |
Sam Sabinsa Group Limited |
| Address |
19/1 & 19/2, I Main, II Phase, Peenya Industrial Area
Bangalore 560 058, Karnataka, India |
| Type of Sponsor |
Other [Manufactures and markets phytonutrients, standardized herbal extracts and nutritional supplements.] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrRaajiv Dorai |
HandeHospital |
44 Lakshmi Talkies Road Shenoy Nagar Chennai600030
Chennai
TAMIL NADU |
9840036314
handehospital@yahoo.com |
| Dr Madhusudhan C |
NRR Hospital |
3&3A Hesaraghatta Road, Chikkabanavara, near to chikkabanavara railway station, Bangalore
Bangalore
KARNATAKA |
7022247227
drmadhusudamadhu123@gmail.com |
| Dr T V S Pradeep |
NUHA Hospitals |
No 12 19 61 62 Old Bank Road Kothapet Guntur522001
Guntur
ANDHRA PRADESH |
9885411254
doctvspradeep@gmail.com |
| Dr Giriraja K V |
Rajalakshmi Hospital |
Rajalakshmi Hospital, #21/1 Lakshmipura Main Road, Vidyaranyapura Post.
Bangalore
KARNATAKA |
09448039952
girirajakv@gmail.com |
| DrA Venkateshwar Rao |
StTheresasHospital |
Sanathnagar,Hyderabad,Telengana-500018,India
Hyderabad
TELANGANA |
9440040662
drvenkateshwarraoavula@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| EthicsCommitteeStTheresas Hospital |
Approved |
| Independent Ethics Committee- CLINISYD Research Global Solutions Private Limited |
Approved |
| Institutional Ethics CommitteeNuha Hospitals |
Approved |
| Rajalakshmi Hospital Institutional Ethics Committee |
Approved |
| RIPON INDEPENDENT ETHICS COMMITTEE (RIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E116||Type 2 diabetes mellitus with other specified complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Metformin | Metformin 500mg tablet- Once a day for 120 days | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: AC3 Beta amyrin, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 101(mg), Frequency: bd, Bhaishajya Kal: Madhyabhakta, Duration: 120 Days, anupAna/sahapAna: Yes(details: anupAna), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants should be willing to give a written informed consent.
2.Participants should be willing to comply with the requirements of the trial/ study.
3.Male and female participants aged between 25-65 years.
4.Females with childbearing potential who agree to use a barrier method of contraception throughout the study period.
5.Participants, newly diagnosed with Type 2 Diabetes (T2DM) and is drug-naive with FBS between126 to 210 mg/dL
PPBS between 200 to 300 mg/dL
HbA1c between 6.5 to 8.9 %.
6.Lipid parameters:
Total Cholesterol between 200 to 300 mg/dL,
Triglyceride between 160 to 300 mg/dL,
LDL between120 to 200 mg/dL.
7.Ability to swallow and retain oral medications as per the protocol.
|
|
| ExclusionCriteria |
| Details |
1. History of Smoking and Alcohol intake (within 3 months before screening)
2. Type-1 Diabetes
3. Presence of chronic gastrointestinal diseases, severe immune deficiencies, lactose intolerance.
4. Use of any lipid lowering therapies in the past 3 months.
5. Patient on antihypertensive medications.
6. Patient with history of clinically significant thyroid disorder, gastrointestinal, cardiovascular, haematological, hepatic, renal, respiratory, active malignancies or genitourinary abnormalities or diseases.
7. Patient who have participated in any clinical trial within the past 3 months.
8. Pregnant and lactating women and those not willing to follow a reliable and effective contraceptive measure during the study.
9. Any planned surgery during study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of beta –amyrin Palmitate with Activated Curcumin Complex (AC3) combination on blood glucose level.
1. Mean percentage change in HbA1c from screening to final visit.
2. Mean change in fasting blood glucose & postprandial blood sugar from screening to final visit. |
1. Screening to 120 days
2. Screening to 120 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare Mean change in lipid profile –TG, LDL, VLDL, HDL, & TC.
2. To compare the mean change in HbA1c, fasting blood glucose and post-prandial blood sugar between active and reference arm.
3. To compare the area under curve (AUC) in serum insulin between active and reference arm.
4. Safety is determined based on the tolerance to amyrin Palmitate with Activated Curcumin Complex (AC3) capsule without any incidence of adverse events. Study Compliance without drop-outs. No adverse change in Complete Blood Count, Urine Routine & Microscopic, Blood chemistry, and incidence of any adverse events during the study period in both the arms. |
1. Screening to 120 days
2. Screening to 120 days
3. Day-1 to 120 days
4. Screening to 120 days |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/10/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study involves 96 subjects randomized in two arms and will receive 120 days of treatment and telephonic follow-up after 7 days following the last visit. Participants will be randomized to receive either Beta-Amyrin Palmitate with activated curcumin complex (Arm-1) or Metformin-500mg (Arm-2) group. Specific biomarkers like fasting blood sugar, serum insulin, HbA1c will be measured and analysed during the study period. The final statical analysis and study report will be complied at the end of the study period. |