| CTRI Number |
CTRI/2015/04/005726 [Registered on: 28/04/2015] Trial Registered Prospectively |
| Last Modified On: |
21/05/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of dietary fiber to improve lipid profile in patients having dyslipidemia. |
|
Scientific Title of Study
|
A clinical study to determine the effect of a dietary fiber on lipid profile in patients with Dyslipidemia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HCHOL-DF-2015 version 2.0 dated 09 Mar 2015 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Almas Pathan |
| Designation |
Principal Investigator |
| Affiliation |
Jehangir Clinical Development Centre Pvt Ltd |
| Address |
Jehangir Clinical Development Centre Pvt Ltd.
Jehangir Hospital Premises,
32 Sassoon Road, Pune- 411001.
Pune
MAHARASHTRA
411001
India |
| Phone |
91-9763002830 |
| Fax |
|
| Email |
almas.jikare@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Almas Pathan |
| Designation |
Principal Investigator |
| Affiliation |
Jehangir Clinical Development Centre Pvt Ltd |
| Address |
Jehangir Clinical Development Centre Pvt Ltd.
Jehangir Hospital Premises,
32 Sassoon Road, Pune- 411001.
Pune
MAHARASHTRA
411001
India |
| Phone |
91-9763002830 |
| Fax |
|
| Email |
almas.jikare@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Almas Pathan |
| Designation |
Principal Investigator |
| Affiliation |
Jehangir Clinical Development Centre Pvt Ltd |
| Address |
Jehangir Clinical Development Centre Pvt Ltd.
Jehangir Hospital Premises,
32 Sassoon Road, Pune- 411001.
Pune
MAHARASHTRA
411001
India |
| Phone |
91-9763002830 |
| Fax |
|
| Email |
almas.jikare@rediffmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
|
Primary Sponsor
Modification(s)
|
| Name |
Mr Ajay Nilawar |
| Address |
5-A,Anupam Society, S H Paralkar Road, Shivaji Park, Dadar, West Mumbai 400028 |
| Type of Sponsor |
Other [Individual] |
|
|
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 Almas Pathan |
Jehangir Clinical Development Centre Pvt Ltd |
JCDC, Clinical Research Dept, Jehangir Hospital Premises,
32 Sassoon Road, Pune- 411001.
Pune
MAHARASHTRA |
91-9763002830
almas.jikare@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Jehangir Clinical Development Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Dyslipidemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dietary Fiber |
It is a sachet of 5gms. It is to be dissolved in a glass of water and to be taken with meals.
Dose: 5 grams twice daily for duration of 8 weeks.(Subject will be instructed to take one sachet along with water once with lunch and once with dinner
). |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Men and women 20 - 65 years of age (both inclusive).
2.Patients with borderline total cholesterol in the range of 195 to 239 mg/dl at screening.
3.Patients with LDL levels in the range of 100 to 130 mg/dl at screening.
4.Must be willing to or likely to comply with all study requirements.
5.Must be able and willing to provide written informed consent.
6.Females of childbearing potential should have a negative pregnancy test at the time of screening and agree to use contraception during the study. |
|
| ExclusionCriteria |
| Details |
•History of cardiovascular disease or Diabetes mellitus
•Intake of nutritional supplements containing fish oil, soy protein, garlic etc.
•Suffering from gastrointestinal diseases that may interfere with nutrient absorption,distribution,metabolism and excretion.eg:Subcaute obstruction
•Current use of medication that may interfere with the digestion and nutrient absorption (for examples steroids, protease inhibitors or antipsychotics medications).
•Known case of sensitivity to Gluten or Coeliac disease.
•Known food allergy or intolerance, abuse of drugs or alcohol
•Pregnant or lactating females.
•Presence of any clinically significant medical conditions or medications which in the opinion of the investigator would make the subject unsuitable for participation in the study.
•Currently participating or had participated in other interventional study in last 1 month prior to screening
•Patients who are unlikely to comply with protocol requirements (e.g. non-cooperative behavior, inability to attend study visits required by the protocol).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
•To determine the effect on total cholesterol
•To determine the effect on Triglycerides
|
At screening, week 4 and week 8
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To determine the effect on HDL cholesterol
• To determine the effect on LDL cholesterol
|
At screening, week 4 and week 8 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/04/2015 |
| 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="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a study in subjects with hypercholesterolemia. The main purpose of this study is to determine the effect of dietary fiber in patients with hyperchloesterolemia. Subjects who have met the eligibility criteria will be enrolled into the study. At the screening visit, retrospective data of subject’s lipid profile (Total cholesterol, HDL Cholesterol, LDL Cholesterol and Triglycerides) of past 8 weeks will be collected.In addition, Lipid profile will be assessed at screening, week 4/ day 29 and week 8/ day 57.
|