Altern Ther Health Med. 2021 Oct;27(S1):196-203.
SARS-CoV-2 is a global public-health concern. Interventions to prevent infection are urgently needed. The anti-inflammatory and antiviral effects of neem make it a potential agent for COVID-19 prophylaxis.
The study intended to evaluate the prophylactic effects of neem capsules for persons at high risk of COVID-19 infection due to contact with COVID-19 positive patients.
The research team designed a prospective, randomized, double-blind, placebo-controlled, parallel-design study.
The study was conducted at a single center in India.
Participants were 190 healthcare workers at the hospital or relatives of patients with COVID-19 infection.
Of the 190 participants, 95 were in the intervention group and 95 in the control group. Participants received 50 mg of a proprietary, patent-pending, neem-leaf extract or a placebo orally in capsules, twice a day for 28 days.
The number of individuals positive for COVID-19 between baseline and follow-up on day 56 was the primary outcome measure. Secondary measures included an evaluation of neem's safety and its effects on quality of life (QOL) and changes in biomarkers.
The mean age of participants was 36.97 years, and 68.42% were male. Total 13 subjects tested positive during the study. All were asymptomatic. Of the 154 participants who completed the study per-protocol, 11 tested positive, 3 in the intervention group and 8 in the control group. The probability of COVID-19 infection in participants receiving the intervention was 0.45 times that of participants receiving the placebo, a relative risk of 0.45, with the effectiveness of the intervention being around 55%. Treatment-emergent adverse events (TEAEs) in both groups were minimal and were of grade 1 or 2 in severity. Biomarkers and QOL remained stable in both groups.
The study found a reduced risk of COVID-19 infection in participants receiving neem capsules, which demonstrates its potential as a prophylactic treatment for the prevention of COVID-19 infection. The findings warrant further investigation in clinical trials.
SARS-CoV-2 是全球公共卫生关注的问题。急需采取干预措施防止感染。印度楝具有抗炎和抗病毒作用，因此可能成为 COVID-19 预防的一种药物。
本研究旨在评估印度楝胶囊对因接触 COVID-19 阳性患者而感染 COVID-19 高风险人群的预防作用。
研究团队设计了一项前瞻性、随机、双盲、安慰剂对照、平行设计的研究。
该研究在印度的一个单一中心进行。
共有 190 名医院的医护人员或 COVID-19 感染患者的亲属参加了该研究。
190 名参与者中，95 名进入干预组，95 名进入对照组。参与者每天口服两次，每次 50 毫克一种专有的、专利待批的印度楝叶提取物或安慰剂胶囊，共 28 天。
主要结局指标是从基线到第 56 天随访时个体 COVID-19 阳性的数量。次要措施包括评估印度楝的安全性及其对生活质量（QOL）的影响和生物标志物的变化。
参与者的平均年龄为 36.97 岁，68.42%为男性。共有 13 名受试者在研究期间检测呈阳性。所有受试者均无症状。154 名按方案完成研究的参与者中，有 11 名检测呈阳性，干预组 3 名，对照组 8 名。接受干预的参与者感染 COVID-19 的概率是接受安慰剂的参与者的 0.45 倍，相对风险为 0.45，干预的有效性约为 55%。两组的治疗中出现的不良事件（TEAEs）都很少，严重程度为 1 级或 2 级。两组的生物标志物和 QOL 保持稳定。
该研究发现，接受印度楝胶囊治疗的参与者 COVID-19 感染风险降低，表明其具有预防 COVID-19 感染的潜力。这些发现值得进一步在临床试验中进行研究。
