PMID- 33352495
OWN - NLM
STAT- MEDLINE
DCOM- 20210224
LR  - 20221207
IS  - 1618-095X (Electronic)
IS  - 0944-7113 (Linking)
VI  - 81
DP  - 2021 Jan
TI  - Efficacy and safety of a herbal drug of Coccinia grandis (Linn.) Voigt in 
      patients with type 2 diabetes mellitus: A double blind randomized placebo 
      controlled clinical trial.
PG  - 153431
LID - S0944-7113(20)30262-2 [pii]
LID - 10.1016/j.phymed.2020.153431 [doi]
AB  - BACKGROUND: Several lines of preclinical studies have shown promising 
      antidiabetic effects of the aqueous leaves extract of Coccinia grandis (Linn.) 
      Voigt (Cucurbitaceae) in vivo and in vitro. PURPOSE: The present study was 
      conducted to evaluate the efficacy and safety of a newly developed herbal 
      formulation of C. grandis in newly diagnosed patients with type 2 diabetes 
      mellitus (T2DM). STUDY DESIGN: A three months long, randomized, double blind, 
      placebo controlled clinical trial in patients with newly diagnosed T2DM. METHOD: 
      Based on fasting plasma glucose (FPG) concentration, a total number of 158 newly 
      diagnosed patients with T2DM (45 +/- 15 years age) were recruited for the present 
      trial from the University Medical Clinic, Teaching Hospital, Karapitiya, Galle, 
      Sri Lanka. They were randomly assigned to the test or placebo group to receive 
      500 mg of herbal drug (n = 79) or placebo drug (n = 79) once daily for three 
      months. Patients and investigators were blinded for the treatment. Percentage of 
      glycated hemoglobin (HbA(1C) %), insulin and lipid profile parameters were 
      estimated at the base line and at the end of the intervention. Serum 
      concentration of fructosamine was assessed at every other visit of the trial. The 
      homeostatic model assessment for insulin resistance (HOMA-IR), atherogenic index 
      (AI), cardio-protective index (CPI) and coronary risk index (CRI) were 
      calculated. Furthermore, fasting plasma glucose concentration, renal and liver 
      toxicity parameters, hematological parameters, blood pressure (BP) were assessed 
      throughout the study in two weekly intervals till the end of three months. 
      RESULTS: Out of 158, a total number of 145 patients completed the entire clinical 
      trial period successfully. Mean (SD) changes of variables from the baseline to 
      the end of the intervention in test and placebo groups were 0.65 (0.54) and 0.08 
      (0.66) for HbA(1C) % (p < 0.001), 1.91 (3.07) and -1.28 (9.77) for insulin (p < 
      0.001), 0.02 (0.03) and -0.01 (0.04) for frucosamine (p < 0.001), 1.51 (0.49) and 
      0.05 (0.50) for FPG (p < 0.001), 1.73 (1.36) and -0.37 (3.38) for HOMA-IR (p < 
      0.001), 0.16 (0.18) and -0.04 (0.42) for TG (p < 0.001), 0.07 (0.08) and -0.02 
      (0.19) for VLDL-C (p < 0.001), respectively. However, the herbal drug of C. 
      grandis was unable to change other outcome variables significantly when compared 
      to the placebo (p > 0.05). All the renal, liver and toxicity parameters, 
      hematological parameters and BP were within the normal physiological reference 
      ranges at each visit. CONCLUSION: Treatment with herbal drug of C. grandis (500 
      mg per day) for three months for patients with newly diagnosed T2DM significantly 
      improved their glycemic and selected lipid profile parameters with well tolerated 
      safety.
CI  - Copyright (c) 2020. Published by Elsevier GmbH.
FAU - Wasana, Keddagoda Gamage Piyumi
AU  - Wasana KGP
AD  - Department of Biochemistry, Faculty of Medicine, University of Ruhuna, Galle, Sri 
      Lanka. Electronic address: piyumi089@gmail.com.
FAU - Attanayake, Anoja Priyadarshani
AU  - Attanayake AP
AD  - Department of Biochemistry, Faculty of Medicine, University of Ruhuna, Galle, Sri 
      Lanka. Electronic address: anoja715@yahoo.com.
FAU - Weerarathna, Thilak Priyantha
AU  - Weerarathna TP
AD  - Department of Medicine, Faculty of Medicine, University of Ruhuna, Galle, Sri 
      Lanka. Electronic address: thilak.priyantha@yahoo.com.
FAU - Jayatilaka, Kamani Ayoma Perera Wijewardana
AU  - Jayatilaka KAPW
AD  - Department of Biochemistry, Faculty of Medicine, University of Ruhuna, Galle, Sri 
      Lanka. Electronic address: ayomawijewardena@yahoo.com.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20201203
PL  - Germany
TA  - Phytomedicine
JT  - Phytomedicine : international journal of phytotherapy and phytopharmacology
JID - 9438794
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin)
RN  - 0 (Lipids)
RN  - 0 (Placebos)
RN  - 0 (hemoglobin A1c protein, human)
SB  - IM
MH  - Adult
MH  - Blood Glucose/drug effects
MH  - Blood Pressure/drug effects
MH  - Cucurbitaceae/*chemistry
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy
MH  - Double-Blind Method
MH  - Female
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Hypoglycemic Agents/chemistry/*therapeutic use
MH  - Insulin/blood
MH  - Insulin Resistance
MH  - Lipids/blood
MH  - Male
MH  - Middle Aged
MH  - Placebos
MH  - Plants, Medicinal/chemistry
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Clinical trial
OT  - Coccinia grandis
OT  - herbal drug
OT  - placebo drug
OT  - type 2 diabetes mellitus
EDAT- 2020/12/23 06:00
MHDA- 2021/02/25 06:00
CRDT- 2020/12/22 20:12
PHST- 2020/05/14 00:00 [received]
PHST- 2020/11/10 00:00 [revised]
PHST- 2020/11/28 00:00 [accepted]
PHST- 2020/12/23 06:00 [pubmed]
PHST- 2021/02/25 06:00 [medline]
PHST- 2020/12/22 20:12 [entrez]
AID - S0944-7113(20)30262-2 [pii]
AID - 10.1016/j.phymed.2020.153431 [doi]
PST - ppublish
SO  - Phytomedicine. 2021 Jan;81:153431. doi: 10.1016/j.phymed.2020.153431. Epub 2020 
      Dec 3.