| CTRI Number |
CTRI/2018/08/015298 [Registered on: 13/08/2018] Trial Registered Prospectively |
| Last Modified On: |
11/08/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [supplementation of Butter Milk Incorporated with Oral Activated Charcoal] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Oral Activated Charcoal in reducing Blood cholesterol levels |
|
Scientific Title of Study
|
Effect of Oral Activated Charcoal on Hyperlipidemic Individuals |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gauri Shivaji Bhoite |
| Designation |
Student |
| Affiliation |
Welcomgroup Graduate School of Hotel Administration |
| Address |
Department of Allied Hospitality studies
(DAHS) Welcomgroup Graduate School of Hotel Administration MAHE Manipal-576104
Udupi
KARNATAKA
576104
India |
| Phone |
9108446949 |
| Fax |
2571383 |
| Email |
nutritionistgauri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Pallavi Shettigar |
| Designation |
Assistant Professor - Selection Grade |
| Affiliation |
Welcomgroup Graduate School of Hotel Administration |
| Address |
Department of Allied Hospitality studies
(DAHS) Welcomgroup Graduate School of Hotel Administration MAHE Manipal-576104
Udupi
KARNATAKA
576104
India |
| Phone |
9591273054 |
| Fax |
2571383 |
| Email |
pallavi.wgsha@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Laaksha Monica Paul Motru |
| Designation |
Student |
| Affiliation |
Welcomgroup Graduate School of Hotel Administration |
| Address |
Department of Allied Hospitality studies
(DAHS) Welcomgroup Graduate School of Hotel Administration MAHE Manipal-576104
Udupi
KARNATAKA
576104
India |
| Phone |
8374969496 |
| Fax |
2571383 |
| Email |
laakshamonica@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pallavi Shettigar, Assistant Professor Selection Grade MSc. Dietetics and Applied Nutrition, Department of Allied Hospitality Studies, Welcomgroup Graduate School of Hotel Administration. |
|
|
Primary Sponsor
|
| Name |
Gauri Shivaji Bhoite |
| Address |
Department of Allied Hospitality Studies (DAHS) Welcomgroup Graduate School of Hotel Administration,MAHE, Manipal-576104 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| AMRUTHA CLINICAL LABORATORIES |
1st FLOOR ,Maruthi Veethika road ,Thenkpete,Udupi. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Gauri Shivaji Bhoite |
Welcomgroup Graduate School of Hotel Administration |
Department of Allied Hospitality Studies ,Welcomgroup Graduate School Of Hotel Administration,Manipal
Udupi
KARNATAKA |
9108446949
2571383
nutritionistgauri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients whose Total cholesterol level is 200-300mg/dl. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Diet and Lifestyle Modification. |
Participant would be prescribed Diet and Lifestyle Modification for 2 and half months
For 0-8 weeks would be prescribed Diet and Lifestyle Modification
For 8-10 weeks they would be kept on withdrawal period |
| Intervention |
Oral Activated Charcoal Incorporated Product (Buttermilk) |
Participant would be kept on Oral Activated Charcoal Incorporated Product (Buttermilk) for 2 and a half months
For 0-4 weeks would be kept on 5g on Oral Activated Charcoal Incorporated Product (Buttermilk)
For 4-8 weeks would be kept on 10g Oral Activated Charcoal Incorporated Product (Buttermilk)
For 8-10 weeks they would be kept on withdrawal period.
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION:
Patients whose Total cholesterol level is 200-300mg/dl would be recruited between the age group of 35 to 65 years including both males and females who are willing to participate.
|
|
| ExclusionCriteria |
| Details |
EXCLUSION:
Age group below 35 years - 65 years above,Pregnant and lactating women and with any other comorbid conditions.Patients that are immuno compromised suffering from terminal illness like HIV, Cancer or those who are under medical treatment.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of accepted activated charcoal product on lipid profile. |
3 times (Pre intervention,end of 4 weeks and 8 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To evaluate the effectiveness of accepted Activated Charcoal product on lipid profile and anthropometric measurements - Height, weight, Hip Circumference, Waist circumference, waist to hip ratio, MUAC, Skin fold thickness (3 sights - chest, abdomen, thigh for men and triceps, suprailliac, thigh for women) of Hyperlipidemic individuals.
|
3 times (Pre intervention,end of 4 weeks and 8 weeks) |
| To study the variation in the lipid profile and anthropometric measurements during the 2 weeks wash out period. |
Only once and at end of 10 weeks of study period. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 |
|
Date of First Enrollment (India)
|
15/08/2018 |
| 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="3"
Days="23" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Hyperlipidemia can be caused by life style changes and dietary habits. According to NIN and ICMR INDIA B data, the prevalence of Hyperlipidemia is high in India. . So, the burden of hyperlipidemia related diseases in India is alarmingly high and is a serious concern. Indians are not only at high risk of developing cardiovascular diseases, they usually get the disease at an early age, have a more severe form of the disease and have poorer outcome as compared to the western populations. The treatment of diseases secondary to dyslipidemia remains costly. For all these reasons, prevention should take priority. As the previous researches were done only on Direct Oral Activated charcoal consumption, so now in this research study a Food product is made which is incorporated with Oral Activated Charcoal with the proportions of 5 grams and 10 grams. According to the Asia Pacific Journal of Multidisciplinary Research it was said that Activated charcoal can be incorporated in the food product as an additive for beneficiary effects .To lower the blood lipids,triglycerides and cholesterol Oral activated charcoal has found to be effective. 1.Preparation and formulating the product with oral activated charcoal. 2 .Standardization and sensory evaluation of Incorporated product with oral activated charcoal .The product that has higher acceptability based on sensory evaluation would be supplemented for experimental group. 3.Participants would be divided into two groups - Experimental Group - which would be supplemented with oral activated charcoal incorporated product and Control Group - which would be prescribed Diet and Lifestyle modification for the period of two and a half months. 4.Data collection would be done using direct personal interview method from a structured questionaire containing socio demographic details. 5.Anthropometric measurements used to evaluate the participants present nutritional status are - Weight ,Height ,MUAC,Body fat composition. 6.The biochemical parameters that would be assessed alipid profile. 7.For Experimental Group - Supplementation of Oral activated charcoal incorporated product from 0-4 weeks , 4-8 weeks and 8-10 weeks withdrawal period. 8.For Control Group - They would be prescribed Diet and Lifestyle modification from 0-8 weeks and 8-10 weeks withdrawal period. 9.In both the groups we would be provided with a questionaire containing various symptoms and they have to score each symptom on the basis of its presence. |