| CTRI Number |
CTRI/2023/09/058019 [Registered on: 26/09/2023] Trial Registered Prospectively |
| Last Modified On: |
15/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Safety and Efficacy of Beta Amyrin Palmitate in newly diagnosed patients of type 2 diabetes mellitus associated with dyslipidaemia. |
|
Scientific Title of Study
|
A two-arm, randomized, double-blinded, placebo-controlled, parallel study to evaluate the efficacy and safety of Beta Amyrin Palmitate in newly diagnosed patients of type 2 diabetes mellitus associated with dyslipidaemia. |
| 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 Shivaprasad C |
| Designation |
Principal Investigator |
| Affiliation |
Sapthagiri Institiute of Medical Sciences and Research Center |
| Address |
Room no. 402, #15, Chikkasandra, Hesaraghatta Main Road, Bengaluru.
Bangalore
KARNATAKA
560090
India |
| Phone |
9900021320 |
| Fax |
|
| Email |
drshivaprasadc@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.
KARNATAKA
560058
India |
| Phone |
08068527777 |
| Fax |
|
| Email |
satish.g@clinworld.net |
|
|
Source of Monetary or Material Support
|
| Sami- Sabinsa Group Limited 19/1 & 19/2, I Main, II Phase, Peenya Industrial Area
Bangalore - 560 058, Karnataka, India |
|
|
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 = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pradeep TVS |
Nuha Hospitals |
No.12 19 61&62,Old BankRoad.Kothapet,Guntur 522001
Guntur
ANDHRA PRADESH |
9885411254
doctvspradeep@gmail.com |
| Dr Shivaprasad |
Sapthagiri Institute of Medical Sciences and Research Center |
Department of Endocrinology, #15, Chikkasandra, Hesaraghatta Main Road, Bengaluru.
Bangalore
KARNATAKA |
09900021320
drshivaprasadc@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| nstitutional Ethics CommitteeNuha Hospitals |
Approved |
| Sapthagiri Institute of Medical Sciences and Research Center Ethics Committee |
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 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Beta Amyrin Palmitate, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Placebo | Micro Crystalline Cellulose capsule dose equivalent to test product. |
|
|
|
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 between 126 to 210 mg/dL, PPBS between 200 to 300 mg/dL and 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 and
LDL between 120 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. Patients 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 has 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 the study.
10. A history of significant multiple and/or severe allergies or anaphylactic reactions.
11. Patient with known history of hypersensitivity to the investigational product.
12. Participant who has participated in any clinical trial within the last 3 months.
13. Any other condition that the Principal Investigator thinks may jeopardize the study.
14. Any other reason(s) as per principal investigator discretion. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of Beta Amyrin Palmitate on blood glucose level.
1. Mean 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 90 days
2. Screening to 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare Mean change in lipid profile- Triglycerides, low density lipid, very low-density lipid, high density lipid & total cholesterol.
2. To compare the mean change in HbA1c, Fasting Blood Glucose and Post-prandial blood sugar.
3. To compare the glucose tolerance (OGTT).
4. Safety is determined based on the tolerance to Beta Amyrin Palmitate without any incidence of adverse events. Study compliance without drop-outs. No adverse change in complete blood count, urine routine and microscopic blood biochemistry, and incidence of any adverse events during the study period in both the arms. |
1. Screening to 90 days
2. Screening to 90 days
3. Day-1 to 90 days
4. Screening to 90 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/09/2023 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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 30 subjects randomized in two arms and will receive 90 days of treatment and telephonic follow-up after 7 days following the last visit. Participants will be randomized to receive either Beta Amyrin Palmitate or Placebo (Microcrystalline Cellulose). Specific biomarkers like fasting blood sugar, serum insulin, HbA1c will be measured and analysed during the study period. The final statistical analysis and study report will be complied at the end of the study period. |