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A randomized, double-blind, parallel-group, placebo-controlled trial of Extract Sceletium tortuosum (Zembrin) in healthy adults.
J Altern Complement Med. 2013 Nov; 19(11):898-904.JA

Abstract

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,(®) 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.

Authors+Show Affiliations

1 Tiervlei Trial Centre (TTC), Karl Bremer Hospital , Bellville, Cape Town, South Africa .No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23441963

Citation

Nell, Haylene, et al. "A Randomized, Double-blind, Parallel-group, Placebo-controlled Trial of Extract Sceletium Tortuosum (Zembrin) in Healthy Adults." Journal of Alternative and Complementary Medicine (New York, N.Y.), vol. 19, no. 11, 2013, pp. 898-904.
Nell H, Siebert M, Chellan P, et al. A randomized, double-blind, parallel-group, placebo-controlled trial of Extract Sceletium tortuosum (Zembrin) in healthy adults. J Altern Complement Med. 2013;19(11):898-904.
Nell, H., Siebert, M., Chellan, P., & Gericke, N. (2013). A randomized, double-blind, parallel-group, placebo-controlled trial of Extract Sceletium tortuosum (Zembrin) in healthy adults. Journal of Alternative and Complementary Medicine (New York, N.Y.), 19(11), 898-904. https://doi.org/10.1089/acm.2012.0185
Nell H, et al. A Randomized, Double-blind, Parallel-group, Placebo-controlled Trial of Extract Sceletium Tortuosum (Zembrin) in Healthy Adults. J Altern Complement Med. 2013;19(11):898-904. PubMed PMID: 23441963.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, double-blind, parallel-group, placebo-controlled trial of Extract Sceletium tortuosum (Zembrin) in healthy adults. AU - Nell,Haylene, AU - Siebert,Mirna, AU - Chellan,Pashini, AU - Gericke,Nigel, Y1 - 2013/02/26/ PY - 2013/2/28/entrez PY - 2013/2/28/pubmed PY - 2014/7/11/medline SP - 898 EP - 904 JF - Journal of alternative and complementary medicine (New York, N.Y.) JO - J Altern Complement Med VL - 19 IS - 11 N2 - 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,(®) 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. SN - 1557-7708 UR - https://www.unboundmedicine.com/medline/citation/23441963/A_randomized_double_blind_parallel_group_placebo_controlled_trial_of_Extract_Sceletium_tortuosum__Zembrin__in_healthy_adults_ L2 - https://www.liebertpub.com/doi/10.1089/acm.2012.0185?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -