A phase I clinical trial to evaluate the safety of thymoquinone-rich black cumin oil (BlaQmax®) on healthy subjects: Randomized, double-blinded, placebo-controlled prospective study

Thomas, Jestin V.; Mohan, ME; Prabhakaran, Prathibha; S, Syam Das; Maliakel, Balu; Krishnakumar, I. M.

doi:10.1016/j.toxrep.2022.04.020

Cited by 18 publications

(24 citation statements)

References 50 publications

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“…However, while the SCR difference is not significant, the trend towards the benefit of using TQF is encouraging. There was no significant difference in the rate of adverse events ( p = 0.16), indicating its safety, which is consistent with a previous Phase 1 study (Thomas et al, 2022). TQF significantly improved the total symptom burden faster ( p < 0.001), and increased cytotoxic CD4 + ( p = 0.04) and helper CD8 + ( p = 0.04) central memory T lymphocytes (Bencheqroun et al, 2022).…”

Section: Thymoquinone and Nigella Sativasupporting

confidence: 90%

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Dietary phytochemicals against COVID‐19: A focus on thymoquinone

2023

eFood

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Section: Thymoquinone and Nigella Sativasupporting

confidence: 90%

“…A phase I clinical trial study showed that TQ‐rich black cumin oil (containing 5% of TQ) was safe at 200 mg/adult/day (Thomas et al, 2022).…”

Section: Thymoquinone and Nigella Sativamentioning

confidence: 99%

Dietary phytochemicals against COVID‐19: A focus on thymoquinone

2023

eFood

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“…A phase I RCT in humans evaluated the safety of oral intake of an NS oil containing 5% TQ (total dose of 200 mg/d) for 90 days. 198 This level of TQ is almost 10-fold higher than amounts in normal cold-pressed oil. No adverse effects on BP, BMI, hematological parameters, and markers of liver and kidney damage were observed.…”

Section: Safetymentioning

confidence: 86%

Black Seeds

Singletary¹

2022

Nutr Today

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Black seeds, sometimes called black cumin, are obtained from the spicy medicinal herb Nigella sativa that is native to a broad region encompassing the eastern Mediterranean, southwest Asia, and northern Africa. The seed and its oil have a distinctive aroma and taste, diversely described as bitter, peppery, metallic, and pungent. Both are frequent ingredients in numerous foods, especially in the Middle East and India. In these same regions N sativa has an extensive history as a folk medicine dating back millenia for relief for a variety of health conditions such as asthma, headache, bronchitis, amenorrhea, allergies, infections, and hypertension. The antioxidant, anti-inflammatory, and immunomodulatory properties of N sativa seeds observed in preclinical studies provided an impetus for clinical trials examining the seeds' effects on cardiovascular, respiratory, and neurological disorders, among others. This narrative review summarizes findings from publications addressing several these and other disorders and provides suggestions for future research.

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“…However, there was a significant difference in HDL and LDL levels. Black cumin seeds can reduce HDL, triglyceride, and cholesterol levels in patients with diabetes mellitus [38].…”

Section: Subject Characteristicsmentioning

confidence: 98%

Herbal supplementation improves clinical outcomes among diabetes mellitus patients

Akrom

Hidayati

Budisetianto

2023

IJPHS

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Hyperglycemic conditions are still common in diabetes melllitus (DM) patients with routine therapy. Rural communities in the Special Region of Yogyakarta habitually consume herbal medicines. Herbal nutritional supplements (MHM) were developed as additional therapy to increase the success of achieving therapeutic targets for DM patients. This study aimed to identify the clinical picture of DM patients who were given MHM at public health center (PHC) in the rural areas of Bantul Regency, Yogyakarta Special Region. This retrospective study was conducted on 94 DM patients with routine therapy. Patients who met the inclusion and exclusion criteria and had agreed to the informed consent were divided into two groups. Patients in the treatment group were asked to consume herbal supplement preparations (MHM) for 20 days. On day 21, each group measured clinical outcome parameters (blood pressure, blood glucose levels, triglycerides, cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), liver enzymes, urea, and creatinine). The mean difference test between the two groups (t-test) was carried out using a 95% confidence level. The results showed that the consumption of MHM herbal nutritional supplements for 20 days reduced blood sugar levels, Hb A1C levels, and urea levels (p<0.05). There were no differences in blood pressure, pulse, cholesterol, triglyceride, HDL, LDL, serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), and creatinine levels between the two groups (p>0.05). Administration of MHM for 20 days increased clinical outcomes in blood sugar, HbA1c, and urea levels in DM patients at PHC.

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A phase I clinical trial to evaluate the safety of thymoquinone-rich black cumin oil (BlaQmax®) on healthy subjects: Randomized, double-blinded, placebo-controlled prospective study

Cited by 18 publications

References 50 publications

Dietary phytochemicals against COVID‐19: A focus on thymoquinone

Dietary phytochemicals against COVID‐19: A focus on thymoquinone

Black Seeds

Herbal supplementation improves clinical outcomes among diabetes mellitus patients

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