Leptin DeficiencyPhase 2CEOLONCT04443790
Clinical Evaluation of Polyherbal Coded Formulation Obesecure for Leptin Regulation and Obesity Management
A Phase 2 study testing Leptin Human in people with Leptin Deficiency and Obesity, run by Hafiz Muhammad Asif at 1 site in Pakistan.
Trial summary
The study was designed to explore an alternative approach to reduce weight in human beings using a polyherbal formulation. A polyherbal formulation named as Obesecure was developed after screening of local medicinal flora. The formulation was further improved after pilot studies and Phase-I Clinical Trials. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Leptin Deficiency, Obesity
- What is being tested?
- Leptin Human
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Apr 2015to 20 May 2018
- Phase
- Phase 2
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients of age20 to 50 years with BMI more than 25
- Only those participants were included who were willing
- Patients of any marital status were included
- Only those participants were included who did not take any antiobesity drug one-month prior to start of study
Who cannot join
- Taking an anti-obesity drug in the previous month
- Pregnant
- Allergic to laxative drugs
- Recurrent weight gain history after antiobesity treatment
- Liver disease
- Taking hormonal therapy, menopausal women
- Diabetes mellitus
- Cardiac problem and hypertension
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
clinical trial was conducted in Karachi,Islamabad and Faisalabad
Karachi, Punjab Province, 74600
About this study
Official title: Obesity Control Through Leptogenic Drugs
The study was designed to explore an alternative approach to reduce weight in human beings using a polyherbal formulation. A polyherbal formulation named as Obesecure was developed after screening of local medicinal flora. The formulation was further improved after pilot studies and Phase-I Clinical Trials.
Read the detailed description
Obesity is a common disease of developing countries including Pakistan. Obesity is a risk factor for many diseases which can be life-threatening or making the person unable to perform daily routine work. Obesity is considered a risk factor for different diseases like cardiovascular diseases, hormonal imbalance, infections, malignancies and chest problems. The leptin hormone has appetite suppressing and energy dissipation activity in the body. A screening study on animals was carried out to find out the leptin enhancing medicinal plants from locally available plants in Pakistan. This study was aimed to see the combined effects of the Leptogenic drug Obesecure on weight management.
Patients of age20 to 50 years with BMI more than 25, not taking any anti-obesity drugs one-month prior to start of study were enrolled. The Participants were randomly allocated to receive either Obesecure or placebo twice a day for three months in Shifa-ul-mulk Hospital, PRIEM Health Care Clinic (Pakistan) and Ria Eastern Medicine Clinic (Pakistan).
An acute toxicity study showed no adverse effect of taking Obesecure prior to clinical trials.
- Conditions
- Leptin Deficiency, Obesity
- Being tested
- Leptin Human
- Medical subject headings
- Obesity, Morbid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leptin HumanDrug
Also called Obesecure
| Study group | Role | What they receive |
|---|---|---|
| Obesecure Capsules (Test Group) | Active comparator | A dose of 500mg capsule twice daily of Polyherbal formulation Obesecure was given in the test group for three months. Short term effectiveness was assessed by BMI calculation on follow up visit after two weeks and long term follow up was assessed by BMI and Leptin Level at three months. Receives: Drug: Leptin Human |
| Plasicure (Control Group) | Placebo comparator | A dose of 500mg capsule twice daily of Placebo as Plasicure was given in the control group for three months. Short term effectiveness was assessed by BMI calculation on follow up visit after two weeks and long term follow up was assessed by BMI and Leptin Level at three months. Receives: Drug: Leptin Human |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leptin Level
Appetite suppression and energy dissipation
Measured: 3 months
BMI (kg/m²) at baseline
weight reduction effects
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start10 Apr 2015
- Primary completion20 Mar 2018
- Study completion20 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Leptin DeficiencyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre, two arm parallel randomized controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hafiz Muhammad Asif
- Sponsor type
- University, hospital or other
- Collaborators
- Hamdard University, Government College University Faisalabad
- Responsible party
- Sponsor-investigator, Hafiz Muhammad Asif, Shifa Ul Mulk Memorial Hospital
- Investigators
- Ejaz Mohiuddin, Ph.D, Study director, Hamdard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443790
- Sponsor's protocol ID
- GCUF/ERC/1817
- Acronym
- CEOLO
- Status last verified
- Jun 2020
- First submitted
- 19 Jun 2020
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be shared to other researchers on request
Publications
Wasim M, Awan FR, Najam SS, Khan AR, Khan HN. Role of Leptin Deficiency, Inefficiency, and Leptin Receptors in Obesity. Biochem Genet. 2016 Oct;54(5):565-72. doi: 10.1007/s10528-016-9751-z. Epub 2016 Jun 16.
PubMed 27313173Farr OM, Gavrieli A, Mantzoros CS. Leptin applications in 2015: what have we learned about leptin and obesity? Curr Opin Endocrinol Diabetes Obes. 2015 Oct;22(5):353-9. doi: 10.1097/MED.0000000000000184.
PubMed 26313897Lee JH, Lee JJ, Cho WK, Yim NH, Kim HK, Yun B, Ma JY. KBH-1, an herbal composition, improves hepatic steatosis and leptin resistance in high-fat diet-induced obese rats. BMC Complement Altern Med. 2016 Sep 13;16(1):355. doi: 10.1186/s12906-016-1265-z.
PubMed 27618865
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity Control Through Leptogenic Drugs
- ClinicalTrials.gov ID
- NCT04443790
- Acronym / sponsor ID
- CEOLO / GCUF/ERC/1817
- Conditions
- Leptin Deficiency, Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Hafiz Muhammad AsifUniversity, hospital or other
- Collaborators
- Hamdard University, Government College University Faisalabad
- Study start
- 10 Apr 2015 (actual)
- Primary completion
- 20 Mar 2018 (actual)
- Study completion
- 20 May 2018 (actual)
- First posted
- 23 Jun 2020 (actual)
- 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.
The study was designed to explore an alternative approach to reduce weight in human beings using a polyherbal formulation. A polyherbal formulation named as Obesecure was developed after screening of local medicinal flora. The formulation was further improved after pilot studies and Phase-I Clinical Trials.
Detailed description
Obesity is a common disease of developing countries including Pakistan. Obesity is a risk factor for many diseases which can be life-threatening or making the person unable to perform daily routine work. Obesity is considered a risk factor for different diseases like cardiovascular diseases, hormonal imbalance, infections, malignancies and chest problems. The leptin hormone has appetite suppressing and energy dissipation activity in the body. A screening study on animals was carried out to find out the leptin enhancing medicinal plants from locally available plants in Pakistan. This study was aimed to see the combined effects of the Leptogenic drug Obesecure on weight management.
Patients of age20 to 50 years with BMI more than 25, not taking any anti-obesity drugs one-month prior to start of study were enrolled. The Participants were randomly allocated to receive either Obesecure or placebo twice a day for three months in Shifa-ul-mulk Hospital, PRIEM Health Care Clinic (Pakistan) and Ria Eastern Medicine Clinic (Pakistan).
An acute toxicity study showed no adverse effect of taking Obesecure prior to clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicentre, two arm parallel randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Obesecure Capsules (Test Group) | Active comparator | Drug: Leptin HumanA dose of 500mg capsule twice daily of Polyherbal formulation Obesecure was given in the test group for three months. Short term effectiveness was assessed by BMI calculation on follow up visit after two weeks and long term follow up was assessed by BMI and Leptin Level at three months. |
| Plasicure (Control Group) | Placebo comparator | Drug: Leptin HumanA dose of 500mg capsule twice daily of Placebo as Plasicure was given in the control group for three months. Short term effectiveness was assessed by BMI calculation on follow up visit after two weeks and long term follow up was assessed by BMI and Leptin Level at three months. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients of age20 to 50 years with BMI more than 25
- Only those participants were included who were willing
- Patients of any marital status were included
- Only those participants were included who did not take any antiobesity drug one-month prior to start of study
Key exclusion criteria (8 listed)
- Taking an anti-obesity drug in the previous month
- Pregnant
- Allergic to laxative drugs
- Recurrent weight gain history after antiobesity treatment
- Liver disease
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 |
|---|---|---|
| Leptin HumanAlso: Obesecure | Drug | Obesecure Capsules (Test Group), Plasicure (Control Group) |
Primary outcome
Leptin Level
Time frame: 3 months
Appetite suppression and energy dissipation
BMI (kg/m²) at baseline
Time frame: 3 Months
weight reduction effects
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 23 Jun 2020.
- Background: PubMed 27313173Wasim M, Awan FR, Najam SS, Khan AR, Khan HN. Role of Leptin Deficiency, Inefficiency, and Leptin Receptors in Obesity. Biochem Genet. 2016 Oct;54(5):565-72. doi: 10.1007/s10528-016-9751-z. Epub 2016 Jun 16.
- Background: PubMed 26313897Farr OM, Gavrieli A, Mantzoros CS. Leptin applications in 2015: what have we learned about leptin and obesity? Curr Opin Endocrinol Diabetes Obes. 2015 Oct;22(5):353-9. doi: 10.1097/MED.0000000000000184.
- Results publication: PubMed 27618865Lee JH, Lee JJ, Cho WK, Yim NH, Kim HK, Yun B, Ma JY. KBH-1, an herbal composition, improves hepatic steatosis and leptin resistance in high-fat diet-induced obese rats. BMC Complement Altern Med. 2016 Sep 13;16(1):355. doi: 10.1186/s12906-016-1265-z.
- Individual participant dataSharing planned: No. IPD will be shared to other researchers on request
Related trials for Leptin Deficiency
RecruitingPhase 3
A Study Evaluating Mibavademab Treatment of Obesity Due to Leptin (LEP) Gene Mutations in Children, Adolescents and Adults
Monogenic Obesity
RecruitingObservational study
Targeting the Hepatic BMP-SMAD Pathway in Leptin Receptor Deficiency (LEPRD)
Leptin Receptor Deficiency Obesity
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.
Ejaz Mohiuddin, Ph.D study director
Hamdard University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Leptin Human in people with Leptin Deficiency and Obesity, run by Hafiz Muhammad Asif at 1 site in Pakistan.
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 4 inclusion and 8 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 23 Jun 2020. 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 Pakistan. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Leptin Level (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04443790, which also lists 3 linked publications.
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 23 Jun 2020.