PrediabetesNCT01680211
Safety and Efficacy Study of Herbal Supplements in Prediabetic and Mild to Moderate Hyperlipidemic Patients
A study testing Salacia bark extract, Salacia leaf extract and Sesame seed extract in people with Prediabetes and Hyperlipidemia, run by Olive Lifesciences Pvt Ltd at 1 site in India.
Trial summary
Objective of this study is to determine the safety and efficacy of administration of herbal supplements (Salacia leaf extract, Salacia root extract and Sesame seed extract) for 6 weeks in the management of prediabetes and mild to moderate hyperlipidemia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Prediabetes, Hyperlipidemia
- What is being tested?
- Salacia bark extract, Salacia leaf extract and Sesame seed extract
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2012to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- As per ATP III guidelines: Baseline LDL ranging 160-189 mg/dL, TC >200 mg/dL and with no or one of the below risk factors
- Current cigarette smoking
- Family history of premature Coronary Heart Disease(CHD); in male first degree relative <55 years; in female first degree relative <65 years)
- Hypertension (BP >140/90 mmHg or on antihypertensive medication)
- Low HDL-C (<40 mg/dL)
- Age (men > 40 years)
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- Impaired glucose tolerance (2-hour post 75 g OGTT glucose levels in the range of ≥140 to ≤ 200 mg/dL)
- Impaired fasting sugar (Fasting blood sugar levels in the range of ≥ 100 to ≤125 mg/dL)
- Being mentally competent and able to understand all study requirements and sign the informed consent form.
Who cannot join
- Patients with severe liver, renal, cardiac or brain diseases.
- Pregnant or lactating women or women of child bearing potential whom are not practicing a reliable form of birth control (either with IUD or with stable usage of oral contraceptives).
- Unable to complete follow up.
- Subjects on any medication that would affect evaluation like Statins.
Trial locations and contacts
1 site in 1 country.
India1 site
Srinivasa Clinic & Diabetic Care Center
Bangalore, Karnataka, 560050
About this study
Official title: Efficacy and Safety Study of Herbal Supplements (SR-L-01, SR-B-01 and SI-S-01) in the Management of Prediabetes and Mild to Moderate Hyperlipidemia
Objective of this study is to determine the safety and efficacy of administration of herbal supplements (Salacia leaf extract, Salacia root extract and Sesame seed extract) for 6 weeks in the management of prediabetes and mild to moderate hyperlipidemia.
- Conditions
- Prediabetes, Hyperlipidemia
- Being tested
- Salacia bark extract, Salacia leaf extract, Sesame seed extract, TLC, Placebo
- Keywords
- Blood Sugar,, Lipoproteins,, Salacia,, Sesame,, Prediabetes,, Hyperlipidemia,, Herbal supplement
- Medical subject headings
- Prediabetic State, Hyperlipidemias, SeSAME syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salacia bark extractDietary supplement
Salacia leaf extractDietary supplement
Sesame seed extractDietary supplement
TLCBehavioural
Lifestyle changes include diet, exercise, weight loss, etc.
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Salacia bark extract (SR-B-01) and TLC | Experimental | Capsules containing 250mg of salacia bark extract,two times a day along with Therapeutic Lifestyle Change (TLC) Receives: Dietary Supplement: Salacia bark extract; Behavioral: TLC |
| Sesame seeds extract (SI-S-01) and TLC | Experimental | Capsules containing 250mg of sesame seed extract,two times a day along with Therapeutic Lifestyle Change (TLC) Receives: Dietary Supplement: Sesame seed extract; Behavioral: TLC |
| Salacia leaf extract (SR-L-01) and TLC | Experimental | Capsules containing 250mg of salacia leaf extract,two times a day along with Therapeutic Lifestyle Change (TLC) Receives: Dietary Supplement: Salacia leaf extract; Behavioral: TLC |
| Placebo and TLC | Placebo comparator | Capsules containing 250mg of placebo,two times a day along with Therapeutic Lifestyle Change (TLC) Receives: Behavioral: TLC; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Blood Sugar and lipid profiles
Change in of blood sugar out come will be measured by Fasting Blood Sugar (FBS), Oral Glucose Tolerance Test (OGTT) and Postprandial Blood Sugar (PPBS). Change in lipid profiles are measured by Low Density Lipoprotein (LDL), Very Low Density Lipoprotein (VLDL), High Density Lipoprotein (HDL) and Total Cholesterol (TC).
Measured: baseline and 6 weeks
Secondary outcomes (1)
Clinical laboratory evaluations
Electrocardiography (ECG), haematology (Complete Blood Count), biochemical tests (blood urea, and serum creatinine), liver function tests and urine routine analysis
Measured: 0 and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olive Lifesciences Pvt Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- K R Raveendra, M.D, Principal investigator, Srinivasa Clinic & Diabetic Care Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01680211
- Sponsor's protocol ID
- OL-S-OB-LP/03-12
- Other IDs
- CTRI/2012/05/002678
- Status last verified
- Sep 2012
- First submitted
- 29 Aug 2012
- Last updated
- 7 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Study of Herbal Supplements (SR-L-01, SR-B-01 and SI-S-01) in the Management of Prediabetes and Mild to Moderate Hyperlipidemia
- ClinicalTrials.gov ID
- NCT01680211
- Acronym / sponsor ID
- OL-S-OB-LP/03-12
- Conditions
- Prediabetes, Hyperlipidemia
- Keywords
- Blood Sugar,, Lipoproteins,, Salacia,, Sesame,, Prediabetes,, Hyperlipidemia,, Herbal supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Olive Lifesciences Pvt LtdIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 7 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective of this study is to determine the safety and efficacy of administration of herbal supplements (Salacia leaf extract, Salacia root extract and Sesame seed extract) for 6 weeks in the management of prediabetes and mild to moderate hyperlipidemia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Salacia bark extract (SR-B-01) and TLC | Experimental | Dietary Supplement: Salacia bark extract, Behavioral: TLCCapsules containing 250mg of salacia bark extract,two times a day along with Therapeutic Lifestyle Change (TLC) |
| Sesame seeds extract (SI-S-01) and TLC | Experimental | Dietary Supplement: Sesame seed extract, Behavioral: TLCCapsules containing 250mg of sesame seed extract,two times a day along with Therapeutic Lifestyle Change (TLC) |
| Salacia leaf extract (SR-L-01) and TLC | Experimental | Dietary Supplement: Salacia leaf extract, Behavioral: TLCCapsules containing 250mg of salacia leaf extract,two times a day along with Therapeutic Lifestyle Change (TLC) |
| Placebo and TLC | Placebo comparator | Behavioral: TLC, Other: PlaceboCapsules containing 250mg of placebo,two times a day along with Therapeutic Lifestyle Change (TLC) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- As per ATP III guidelines: Baseline LDL ranging 160-189 mg/dL, TC >200 mg/dL and with no or one of the below risk factors
- Impaired glucose tolerance (2-hour post 75 g OGTT glucose levels in the range of ≥140 to ≤ 200 mg/dL)
- Impaired fasting sugar (Fasting blood sugar levels in the range of ≥ 100 to ≤125 mg/dL)
- Being mentally competent and able to understand all study requirements and sign the informed consent form.
Key exclusion criteria (4 listed)
- Patients with severe liver, renal, cardiac or brain diseases.
- Pregnant or lactating women or women of child bearing potential whom are not practicing a reliable form of birth control (either with IUD or with stable usage of oral contraceptives).
- Unable to complete follow up.
- Subjects on any medication that would affect evaluation like Statins.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salacia bark extract | Dietary supplement | Salacia bark extract (SR-B-01) and TLC |
| Salacia leaf extract | Dietary supplement | Salacia leaf extract (SR-L-01) and TLC |
| Sesame seed extract | Dietary supplement | Sesame seeds extract (SI-S-01) and TLC |
| TLCLifestyle changes include diet, exercise, weight loss, etc. | Behavioural | Placebo and TLC, Salacia bark extract (SR-B-01) and TLC, Salacia leaf extract (SR-L-01) and TLC, Sesame seeds extract (SI-S-01) and TLC |
| Placebo | Other | Placebo and TLC |
Primary outcome
Change in Blood Sugar and lipid profiles
Time frame: baseline and 6 weeks
Change in of blood sugar out come will be measured by Fasting Blood Sugar (FBS), Oral Glucose Tolerance Test (OGTT) and Postprandial Blood Sugar (PPBS). Change in lipid profiles are measured by Low Density Lipoprotein (LDL), Very Low Density Lipoprotein (VLDL), High Density Lipoprotein (HDL) and Total Cholesterol (TC).
1 secondary outcome
Clinical laboratory evaluations
Time frame: 0 and week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
K R Raveendra, M.D principal investigator
Srinivasa Clinic & Diabetic Care Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salacia bark extract, Salacia leaf extract and Sesame seed extract in people with Prediabetes and Hyperlipidemia, run by Olive Lifesciences Pvt Ltd at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Blood Sugar and lipid profiles (time frame: baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2012.