PMID- 23441963
OWN - NLM
STAT- MEDLINE
DCOM- 20140710
LR  - 20140731
IS  - 1557-7708 (Electronic)
IS  - 1075-5535 (Linking)
VI  - 19
IP  - 11
DP  - 2013 Nov
TI  - A randomized, double-blind, parallel-group, placebo-controlled trial of Extract 
      Sceletium tortuosum (Zembrin) in healthy adults.
PG  - 898-904
LID - 10.1089/acm.2012.0185 [doi]
AB  - OBJECTIVES: The objective of the study was to evaluate the safety and 
      tolerability of two doses (8 mg and 25 mg once daily) of a 2:1 standardized 
      extract of the South African medicinal plant Sceletium tortuosum (L.) N.E. Br., 
      trademarked Zembrin,((R)) in healthy adult volunteers over a three-month period. 
      DESIGN: This was a randomized, double-blind, parallel-group, placebo-controlled 
      single center study. SETTING: Tiervlei Trial Centre, Karl Bremer Hospital, 
      Bellville, Cape Town, South Africa. PARTICIPANTS: The study took place between 
      February 2 and July 27, 2009. Thirty-seven healthy adults were recruited from the 
      general population. INTERVENTION: Participants were randomized to receive either 
      one of two doses of study medication, or an identical placebo, taken once daily 
      for 3 months. Of the 37 subjects, 12, 12, and 13 subjects received 8 mg extract 
      Sceletium tortuosum (Zembrin), 25 mg extract Sceletium tortuosum (Zembrin), and 
      placebo treatment, respectively. OUTCOME MEASURES: No efficacy variables were 
      assessed. The safety and tolerability variables comprised of vital signs, 
      physical examination, 12-lead electrocardiogram (ECG), laboratory assessments 
      (hematology, biochemistry, and urinalysis), and the recording of adverse events 
      (AEs). RESULTS: There were no apparent differences between the three treatments 
      with regard to vital signs, 12-lead ECG, body weight, and physical examination 
      from screening to the end of the 3-month treatment period. No significant changes 
      were observed in hematology or biochemistry parameters between initial screening 
      and the end of the study. Both doses of extract Sceletium tortuosum (Zembrin) 
      were well-tolerated. The most commonly reported AE was headache, followed by 
      abdominal pain and upper respiratory tract infections, all with greater incidence 
      in the placebo group than in the treatment groups. Unsolicited positive effects 
      on well-being were noted in patient diaries by some participants taking extract 
      Sceletium tortuosum (Zembrin), including improved coping with stress and sleep. 
      CONCLUSION: Both doses of extract Sceletium tortuosum (Zembrin) (8 mg and 25 mg) 
      were well tolerated when used by healthy human subjects once daily for 3 months.
FAU - Nell, Haylene
AU  - Nell H
AD  - 1 Tiervlei Trial Centre (TTC), Karl Bremer Hospital , Bellville, Cape Town, South 
      Africa .
FAU - Siebert, Mirna
AU  - Siebert M
FAU - Chellan, Pashini
AU  - Chellan P
FAU - Gericke, Nigel
AU  - Gericke N
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130226
PL  - United States
TA  - J Altern Complement Med
JT  - Journal of alternative and complementary medicine (New York, N.Y.)
JID - 9508124
RN  - 0 (Plant Extracts)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Body Weight/drug effects
MH  - Double-Blind Method
MH  - Electrocardiography/drug effects
MH  - Female
MH  - Humans
MH  - Male
MH  - Mesembryanthemum/*chemistry
MH  - Middle Aged
MH  - Plant Extracts/*administration & dosage/adverse effects
MH  - Plants, Medicinal/*chemistry
MH  - Vital Signs/drug effects
MH  - Young Adult
EDAT- 2013/02/28 06:00
MHDA- 2014/07/11 06:00
CRDT- 2013/02/28 06:00
PHST- 2013/02/28 06:00 [entrez]
PHST- 2013/02/28 06:00 [pubmed]
PHST- 2014/07/11 06:00 [medline]
AID - 10.1089/acm.2012.0185 [doi]
PST - ppublish
SO  - J Altern Complement Med. 2013 Nov;19(11):898-904. doi: 10.1089/acm.2012.0185. 
      Epub 2013 Feb 26.