amoypt

Property	Value
?:abstract	BACKGROUND: COVID-19 has caused havoc across the globe since, no specific treatment exists for this disease, thus, far. Hence, there is an urgent need to find an effective treatment to mitigate this scourge. Honey and Nigella sativa are two natural substances with anti-inflammatory, anti-viral, anti-microbial and immune modulating properties. They could be potentially beneficial in these patients. METHODS: We conducted an add-on, randomized, open label, placebo-controlled clinical trial using parallel group design. This was a multi-centered study with superiority framework conducted in RT-PCR confirmed COVID-19 patients showing moderate or severe disease. All patients receiving standard care were randomized into treatment and control groups. In the treatment arm, patients received HNS (honey plus Nigella sativa) in predefined doses for up to 13 days. The primary outcome measures (time taken for alleviation of symptoms, viral clearance and clinical status improvement on day 6) outcomes were assessed. RESULTS: Of 1046 patients testing positive for the SARS-CoV-2, 210 showing moderate and 103 showing severe disease were randomized into treatment and control groups as per inclusion criteria. In the moderate cases, 107 were assigned to the HNS group and 103 to the control group. Among 103 severe cases, 50 were assigned to the HNS group and 53 to the control group. In the moderate and severe cases, the HNS treatment was associated with a normalized median symptoms alleviation time reduction of 3 and 7 days (HR: 6.11; 95% CI: 4.23-8.84 and HR: 4.04; 95% CI, 2.46-6.64) respectively. The HNS treatment in both groups were further associated with 4 days earlier reduction in median viral clearance time (Moderate HR: 5.53; 95% CI: 3.76-8.14) and Severe HR: 4.32; 95% CI: 2.62-7.13). Moreover, in the intention-to-treat analysis, the HNS groups led to a lower (better) clinical score on day 6 with resumption of normal activity among 63.6% of the moderate (OR: 0.07; 95% CI: 0.03-0.13) and 28% of severe cases (OR: 0.03; 95% CI: 0.01-0.09). Furthermore, a significant (14.87%) reduction (OR: 0.18; 95% CI: 0.02-0.92) in mortality was observed in the HNS arm. No difference in adverse effects were seen between the HNS and control arms. CONCLUSIONS: A significant reduction in in the severity of disease, the time taken for viral clearance and mortality was observed with HNS treatment in COVID-19 patients. HNS represents a safe, effective, over the counter and affordable therapy for this pandemic essentially lowering health care burden. It can be used alone or in combination with other expensive treatments and give an additive effect. Hence, the potential of HNS against COVID-19 should be explored in future larger studies. (Funded by Smile Welfare Organization, Shaikh Zayed Medical Complex and Services Institute of Medical Sciences; NIH Clinical Trial Register number: NCT04347382.)
is ?:annotates of	<https://research.tib.eu/covid-19/entity/93amoypt_hasAnnotation_C0003209> <https://research.tib.eu/covid-19/entity/93amoypt_hasAnnotation_C0013231> <https://research.tib.eu/covid-19/entity/93amoypt_hasAnnotation_C0206655> <https://research.tib.eu/covid-19/entity/93amoypt_hasAnnotation_C0879626> <https://research.tib.eu/covid-19/entity/93amoypt_hasAnnotation_C1457887> <https://research.tib.eu/covid-19/entity/93amoypt_hasAnnotation_C3715044> <https://research.tib.eu/covid-19/entity/93amoypt_hasAnnotation_C5203676>
?:creator	<https://research.tib.eu/covid-19/entity/Ashraf%2C_S.%3B_Ashraf%2C_M.%3B_Imran%2C_M._A.%3B_Kalsoom%2C_L.%3B_Siddiqui%2C_U._N.%3B_Ghufran%2C_M.%3B_Majeed%2C_N.%3B_Farooq%2C_I.%3B_Habib%2C_Z.%3B_Hilal%2C_A.%3B_Abdin%2C_Z._u.%3B_Khaqan%2C_A.%3B_Akram%2C_M._K.%3B_Akmal%2C_R.%3B_Rafique%2C_S.%3B_Nawaz%2C_K.%3B_Arshad%2C_S.%3B_Ahmad%2C_S.%3B_Hayat%2C_K.%3B_Arshad%2C_A.%3B_Nadeem%2C_M._F.%3B_Hassan%2C_M.%3B_Awais%2C_A._b.%3B_Azam%2C_M.%3B_Suhail%2C_M.%3B_Zulfiqar%2C_S.%3B_Anwar%2C_I.%3B_Sarfraz%2C_S.%3B_Humayun%2C_A.%3B_Malik%2C_A.%3B_Zheng%2C_H.%3B_Mahmud%2C_T.%3B_Ayyaz%2C_M.%3B_Ahmad%2C_A.%3B_Saboor%2C_Q._A.%3B_Izhar%2C_M.>
?:doi	10.1101/2020.10.30.20217364
?:doi	<https://research.tib.eu/covid-19/entity/10.1101/2020.10.30.20217364>
?:license	medrxiv
?:pdf_json_files	document_parses/pdf_json/88e01a7c6307bd4d5fad15defc91c0d339235b2b.json
?:publication_isRelatedTo_Disease	<https://research.tib.eu/covid-19/entity/COVID-19>
?:sha_id	<https://research.tib.eu/covid-19/entity/88e01a7c6307bd4d5fad15defc91c0d339235b2b>
?:source	MedRxiv; WHO
?:title	Therapeutic efficacy of Honey and Nigella sativa against COVID-19: A multi-center randomized controlled clinical trial (HNS-COVID-PK)
?:type	<https://research.tib.eu/covid-19/vocab/Publication>
?:year	2020-11-03

Property

Value

?:abstract

BACKGROUND: COVID-19 has caused havoc across the globe since, no specific treatment exists for this disease, thus, far. Hence, there is an urgent need to find an effective treatment to mitigate this scourge. Honey and Nigella sativa are two natural substances with anti-inflammatory, anti-viral, anti-microbial and immune modulating properties. They could be potentially beneficial in these patients. METHODS: We conducted an add-on, randomized, open label, placebo-controlled clinical trial using parallel group design. This was a multi-centered study with superiority framework conducted in RT-PCR confirmed COVID-19 patients showing moderate or severe disease. All patients receiving standard care were randomized into treatment and control groups. In the treatment arm, patients received HNS (honey plus Nigella sativa) in predefined doses for up to 13 days. The primary outcome measures (time taken for alleviation of symptoms, viral clearance and clinical status improvement on day 6) outcomes were assessed. RESULTS: Of 1046 patients testing positive for the SARS-CoV-2, 210 showing moderate and 103 showing severe disease were randomized into treatment and control groups as per inclusion criteria. In the moderate cases, 107 were assigned to the HNS group and 103 to the control group. Among 103 severe cases, 50 were assigned to the HNS group and 53 to the control group. In the moderate and severe cases, the HNS treatment was associated with a normalized median symptoms alleviation time reduction of 3 and 7 days (HR: 6.11; 95% CI: 4.23-8.84 and HR: 4.04; 95% CI, 2.46-6.64) respectively. The HNS treatment in both groups were further associated with 4 days earlier reduction in median viral clearance time (Moderate HR: 5.53; 95% CI: 3.76-8.14) and Severe HR: 4.32; 95% CI: 2.62-7.13). Moreover, in the intention-to-treat analysis, the HNS groups led to a lower (better) clinical score on day 6 with resumption of normal activity among 63.6% of the moderate (OR: 0.07; 95% CI: 0.03-0.13) and 28% of severe cases (OR: 0.03; 95% CI: 0.01-0.09). Furthermore, a significant (14.87%) reduction (OR: 0.18; 95% CI: 0.02-0.92) in mortality was observed in the HNS arm. No difference in adverse effects were seen between the HNS and control arms. CONCLUSIONS: A significant reduction in in the severity of disease, the time taken for viral clearance and mortality was observed with HNS treatment in COVID-19 patients. HNS represents a safe, effective, over the counter and affordable therapy for this pandemic essentially lowering health care burden. It can be used alone or in combination with other expensive treatments and give an additive effect. Hence, the potential of HNS against COVID-19 should be explored in future larger studies. (Funded by Smile Welfare Organization, Shaikh Zayed Medical Complex and Services Institute of Medical Sciences; NIH Clinical Trial Register number: NCT04347382.)

is ?:annotates of