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Type 2 DiabetesPhase 2NCT00823953

Glycemic Response to Momordica Charantia in Type 2 Diabetes

A Phase 2 study testing Momordica charantia and starch powder in people with Type 2 Diabetes, run by Services Hospital, Lahore at 1 site in Pakistan.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Diabetes is a common disease which has been treated by traditional medicines for centuries before modern medicine became available. A very common remedy for Diabetes Mellitus in different cultures is momordica charantia (karela or Bitter gourd). The use of alternative medicine is common among Pakistani population. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
Momordica charantia and starch powder
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 sitePakistan
Study dates
Nov 2008to Feb 2009
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult Type 2 diabetics with mild degree of hyperglycemia (FBG >126<200 mg/dl)
  • Absence of serious co-morbid conditions
  • Patients agreeing to participate in this trial

Who cannot join

  • Type 1 diabetics
  • Pregnancy
  • Paediatric age group
  • Patients known to be allergic to Momordica charantia
  • Serious cardio-respiratory illness, previous myocardial infarction, angina pectoris, heart failure, uncontrolled hypertension ≥ stage 2, COPD, asthma, active pulmonary tuberculosis
  • Significant hepatic impairment: ALT >60, Bilirubin >2 mg/dl
Show all 12Show fewer
  • Significant renal impairment: S/creatinine >1.5 mg/dl, albuminuria > 1+
  • Patients with conditions likely to interfere with the absorption of the trial therapy: malabsorption, chronic diarrhoea, intestinal resection, blind loop syndrome
  • Patients withholding consent
  • Patients, both male and female, desiring pregnancy during the trial phase.
  • Secondary causes of diabetes
  • Patients using drugs influencing glucose metabolism: steroids, hormonal contraception, menopausal HRT , diazoxide, phenytoin, colchicine

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Services Hospital

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

Official title: The Effect of Momordica Charantia on Glycemic Control and Insulin Resistance in Type 2 Diabetes

Diabetes is a common disease which has been treated by traditional medicines for centuries before modern medicine became available. A very common remedy for Diabetes Mellitus in different cultures is momordica charantia (karela or Bitter gourd). The use of alternative medicine is common among Pakistani population. This study was planned to find out the effect of administering freeze dried powder of momordica charantia for three weeks on the glycemic profile and insulin resistance of treatment naiive patients with mild Type 2 diabetes.

Read the detailed description

Momordica charantia is a commonly consumed vegetable, which has formed a part of subcontinental diet since centuries. It has been traditionally used to treat diabetes across three continents, and its glycemic effect has been investigated in a few unblinded trials, but so far no properly designed double blind investigation of its action on insulin resistance has not been carried out. In this study, a randomised placebo controlled double-blind trial will be carried out on mild type 2 diabetic patients, to study the effect of escalating doses of Momordica charantia administered in the form of capsules for the trial phase of three weeks, on glycemic control and parameters of insulin resistance in type 2 diabetes. Among the parameters to be tested will be glucose indices and lipid profile and insulin levels. The effect of Momordica charantia administration on insulin resistance will be assessed using HOMA-IR model and/ or the hyperinsulinemic, euglycemic clamp. The selection of patients with mild hyperglycemia will be done to offset the glucose spill-off effect which occurs beyond the real threshold, and makes the glucose tolerance curve non-linear beyond this level.

Conditions
Type 2 Diabetes
Being tested
Momordica charantia, starch powder
Keywords
diabetes type 2
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Momordica charantiaDrug

    Also called Bitter Melon Capsule

    escalating doses of Momordica charantia administered in the form of capsules for the trial phase of three week.Dose level 1: capsules containing a total of 500 mg of freeze dried powder of Momordica charantia. Dose level 1: capsules containing a total of 1000 mg of freeze dried powder of Momordica charantia. Dose level 3: capsules containing a total of 1500mg of freeze dried powder of Momordica charantia.

  • starch powderOther

    The placebo arm will be administered capsules containing a total of 500 mg of starch powder, at dose level 1; 1000 mg at dose level 2; 1500 mg at dose level 3.

Study groups in NCT00823953
Study groupRoleWhat they receive
PlaceboPlacebo comparatorplacebo powder (wheat flour) The placebo arm will be administered capsules containing a total of 500 mg of starch powder, at dose level 1; 1000 mg at dose level 2; 1500 mg at dose level 3.
Receives: Other: starch powder
Momordica charantiaActive comparatorThirty patients will be assigned to each arm in a double blind manner. The active arm will be administered capsules containing a total of 500 mg of Momordica charantia freeze dried powder, at dose level 1; 1000 mg at dose level 2; 1500 mg at dose level 3. The placebo arm will be administered capsules containing a total of 500 mg of starch powder, at dose level 1; 1000 mg at dose level 2; 1500 mg at dose level 3.
Receives: Drug: Momordica charantia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. serum fructosamine at end of trial phase in each of the groups

    Measured: three weeks

Secondary outcomes (5)

  1. Development of major adverse effects (e.g. intractable vomiting, jaundice, allergic reactions or other effects requiring cessation of therapy and breaking of study code)

    Measured: three weeks

  2. GLP-1[7-36] in each group at the end of trial phase

    Measured: three weeks

  3. FBG at end of trial phase in each of the groups

    Measured: three weeks

  4. HOMA-IR in each of the two groups at end of trial phase

    Measured: three weeks

  5. Insulin resistance by the hyperinsulinemic, euglycemic clamp in a subset at the end of trial phase

    Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2009 (estimated)
  2. Study startNov 2008
  3. Primary completionFeb 2009
  4. Study completionFeb 2009

Why it stopped: IP could not be made available in sufficient quantity for the expected enrollment

Resources

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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00823953
Sponsor's protocol ID
DMC0107
Status last verified
Jun 2012
First submitted
15 Jan 2009
Last updated
12 Jun 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Ahmed I, Adeghate E, Sharma AK, Pallot DJ, Singh J. Effects of Momordica charantia fruit juice on islet morphology in the pancreas of the streptozotocin-diabetic rat. Diabetes Res Clin Pract. 1998 Jun;40(3):145-51. doi: 10.1016/s0168-8227(98)00022-9.

    PubMed 9716917

  • Ahmed I, Lakhani MS, Gillett M, John A, Raza H. Hypotriglyceridemic and hypocholesterolemic effects of anti-diabetic Momordica charantia (karela) fruit extract in streptozotocin-induced diabetic rats. Diabetes Res Clin Pract. 2001 Mar;51(3):155-61. doi: 10.1016/s0168-8227(00)00224-2.

    PubMed 11269887

  • Dans AM, Villarruz MV, Jimeno CA, Javelosa MA, Chua J, Bautista R, Velez GG. The effect of Momordica charantia capsule preparation on glycemic control in type 2 diabetes mellitus needs further studies. J Clin Epidemiol. 2007 Jun;60(6):554-9. doi: 10.1016/j.jclinepi.2006.07.009. Epub 2006 Nov 13.

    PubMed 17493509

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Momordica charantia and starch powder in people with Type 2 Diabetes, run by Services Hospital, Lahore 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 3 inclusion and 12 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: withdrawn, as of the sponsor's last update on 12 Jun 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 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 was withdrawn before enrolling participants, so there are no results.

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?

serum fructosamine at end of trial phase in each of the groups (time frame: three weeks). 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 NCT00823953, 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 12 Jun 2012.

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