| CTRI Number |
CTRI/2023/05/052246 [Registered on: 02/05/2023] Trial Registered Prospectively |
| Last Modified On: |
29/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Sil oil in Diabetes, hypertension and high Cholesterol levels. |
|
Scientific Title of Study
|
A Prospective, Comparative, Open label Clinical Study to evaluate the Efficacy and Safety of Livvel Silk oil Soft gel Capsules in patients with Diabetes mellitus, Hypertension and Hyperlipidemia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SILKOIL/01/23 Version: 1.0 dated 15.01.2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Uma Narayanamurthy MD |
| Designation |
Associate professor and PI |
| Affiliation |
MGMC&RI |
| Address |
Room no.2, Dept. of Pharmacology, Mahathma Gandhi Medical College Research Institute Puducherry Cuddalore Main Road Pillaiyarkuppam Puducherry
Pondicherry
PONDICHERRY
607 403
India |
| Phone |
9842329417 |
| Fax |
|
| Email |
numa.lally@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Sakthi Balan MD |
| Designation |
Consultant and CI |
| Affiliation |
kai3 |
| Address |
No 408 Cuddalore Road Nainarmandapan Puducherry
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9443627722 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri Sivakumar |
| Designation |
CEO |
| Affiliation |
Kai3 |
| Address |
Room no.1, Ki3 Office, Regus Centre Level 2 Altius Block No 1 SIDCO Industrial Estate Chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
9003109416 |
| Fax |
|
| Email |
Venkat_ani2007@yahoo.Co.in |
|
|
Source of Monetary or Material Support
|
| SEIDECOSAA Division of M/s INDIAN SILK FIBRE CO, India |
|
|
Primary Sponsor
|
| Name |
SEIDECOSAA Division of M/s INDIAN SILK FIBRE CO, India |
| Address |
414 Hal 2nd Stage 7th Main 1st Cross Indiranagar Bangalore |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Uma Narayanamurthy |
Mahathma Gandhi Medical College and Research Institute |
Room no. 3, Dept. of Pharmacology, MGMCRI, Puducherry Cuddalore Main Road Pillaiyarkuppam Puducherry
Pondicherry
PONDICHERRY |
9842329417
numa.lally@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahathma Gandhi Medical College and Research Institute EC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E115||Type 2 diabetes mellitus with circulatory complications, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | tab. Metformin 500 mg, Tab. Glimepride 1/2 mg, Tab. Atorvastatin 10 / 20 mg and Tab. Telmesartan 40 mg/ Tab. Enalapril 5 mg, as monotheraphy or combination theraphy | tab. Metformin 500 mg, Tab. Glimepride 1/2 mg, Tab. Atorvastatin 10 / 20 mg and Tab. Telmesartan 40 mg/ Tab. Enalapril 5 mg. for 12 weeks. | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Livvel silk oil, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 100(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Subjects, aged 18 years and above.
Subjects diagnosed with Diabetes with hypertension and hyperlipidaemia, (newly diagnosed and patients who are on treatment).
|
|
| ExclusionCriteria |
| Details |
1. Subjects presenting with any other life threatening co morbid disease conditions like renal failure, liver failure or severe heart failure.
2. Participation in any other clinical study or test panel within the one month prior to entry into the study.
3. History of allergy to test product
4. History of HIV, HBV, Malignancy, alcohol or drug abuse.
5. Pregnant or lactating subjects. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Polyphagia, Polyurea, Polydipsia, Fatigue, weight loss and Blur vision (if any)
• Fasting blood glucose, Post prandial blood glucose and HbA1c levels
• Improvement of Systolic and Diastolic blood pressure
• Lowering of LDL/VLDL/TG and increase in HDL
• Number of Cardiovascular events (myocardial infarction/ stroke) during the study period.
• Improvement of Inflammatory markers like ESR and CRP.
|
4th 8th and 12th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Patient and investigator feedbacks and Quality of Life will be assessed
• Adverse event monitoring (Laboratory data will be compared Pre and Post study to monitor for the safety of the subjects).
|
4th 8th and 12th week |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
08/05/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
- The subjects who fulfilled the inclusion
and exclusion criteria will be enrolled in the study.
- 100 Participants will be
randomized into 2 groups with 50 in each group.
- Arm 1 - Silk oil soft gel capsules + Standard
Treatment for Diabetes, Hypertension and Hyperlipidemia: 50 study participants
- Arm 2 - Standard Treatment for Diabetes,
Hypertension and Hyperlipidemia: 50 study participants
|