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History of Changes for Study: NCT00823953
Glycemic Response to Momordica Charantia in Type 2 Diabetes
Latest version (submitted June 9, 2012) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 15, 2009 None (earliest Version on record)
2 June 9, 2012 Recruitment Status, Study Status, Sponsor/Collaborators, Contacts/Locations and Study Design
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Study NCT00823953
Submitted Date:  June 9, 2012 (v2)

Open or close this module Study Identification
Unique Protocol ID: DMC0107
Brief Title: Glycemic Response to Momordica Charantia in Type 2 Diabetes
Official Title: The Effect of Momordica Charantia on Glycemic Control and Insulin Resistance in Type 2 Diabetes
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2012
Overall Status: Withdrawn [IP could not be made available in sufficient quantity for the expected enrollment]
Study Start: November 2008
Primary Completion: February 2009 [Actual]
Study Completion: February 2009 [Actual]
First Submitted: January 15, 2009
First Submitted that
Met QC Criteria:
January 15, 2009
First Posted: January 16, 2009 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 9, 2012
Last Update Posted: June 12, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Services Hospital, Lahore
Responsible Party: Principal Investigator
Investigator: Khadija Irfan Khawaja
Official Title: Assistant Professor of Endocrinology
Affiliation: Services Hospital, Lahore
Collaborators: University of the Punjab
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief 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. 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.
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.
Open or close this module Conditions
Conditions: Type 2 Diabetes
Keywords: diabetes type 2
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 0 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Placebo Comparator: Placebo
placebo 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.
starch powder
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.
Active Comparator: Momordica charantia

Thirty 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.

Drug: Momordica charantia
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.
Other Names:
  • Bitter Melon Capsule
Open or close this module Outcome Measures
Primary Outcome Measures:
1. serum fructosamine at end of trial phase in each of the groups

[Time Frame: three weeks]
Secondary Outcome Measures:
2. Development of major adverse effects (e.g. intractable vomiting, jaundice, allergic reactions or other effects requiring cessation of therapy and breaking of study code)

[Time Frame: three weeks]
3. GLP-1[7-36] in each group at the end of trial phase

[Time Frame: three weeks]
4. FBG at end of trial phase in each of the groups

[Time Frame: three weeks]
5. HOMA-IR in each of the two groups at end of trial phase

[Time Frame: three weeks]
6. Insulin resistance by the hyperinsulinemic, euglycemic clamp in a subset at the end of trial phase

[Time Frame: 3 weeks]
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

  1. Type 1 diabetics
  2. Pregnancy
  3. Paediatric age group
  4. Patients known to be allergic to Momordica charantia
  5. Serious cardio-respiratory illness, previous myocardial infarction, angina pectoris, heart failure, uncontrolled hypertension ≥ stage 2, COPD, asthma, active pulmonary tuberculosis
  6. Significant hepatic impairment: ALT >60, Bilirubin >2 mg/dl
  7. Significant renal impairment: S/creatinine >1.5 mg/dl, albuminuria > 1+
  8. Patients with conditions likely to interfere with the absorption of the trial therapy: malabsorption, chronic diarrhoea, intestinal resection, blind loop syndrome
  9. Patients withholding consent
  10. Patients, both male and female, desiring pregnancy during the trial phase.
  11. Secondary causes of diabetes
  12. Patients using drugs influencing glucose metabolism: steroids, hormonal contraception, menopausal HRT , diazoxide, phenytoin, colchicine
Open or close this module Contacts/Locations
Study Officials: Khadija I Khawaja, MBBS,FCPS
Principal Investigator
Services Hospital, Lahore
Locations: Pakistan, Punjab
Services Hospital
Lahore, Punjab, Pakistan, 54000
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations: 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. 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. 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. Epub 2006 Nov 13. PubMed 17493509
Links: Description: Database File for Momordica charantia
Available IPD/Information:

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