A blend of Withania somnifera (L.) Dunal root and Abelmoschus esculentus (L.) Moench fruit extracts relieves constipation and improves bowel function: A proof-of-concept clinical investigation
Punukollu RS, Chadalawada AK, Siddabattuni K, Gogineni NT
Journal of ethnopharmacology · 13 citas
Etiquetas de revisión
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2023-08-04 · J Ethnopharmacol · vol. 318 · número Pt B · pág. 116997
- Editorial
- Elsevier BV
- Citado
- 20 citas · más que el 96% de estudios similares · 4.7× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 99 trabajos
- Acceso
- De pago
- Áreas de investigación
- Gastrointestinal motility and disorders · Phytochemicals and Medicinal Plants · Traditional Chinese Medicine Studies
- Palabras clave
- Withania somnifera, okra, functional constipation, herbal supplements, ashwagandha root extract, sleep quality, stress reduction, gastrointestinal function, quality of life, serum biomarkers, tolerability, Rome III criteria, PAC-QOL, Gastrointestinal Symptom Rating Scale
- MeSH
- humans, abelmoschus, withania, fruit, constipation, plant extracts, defecation, quality of life, adult, middle aged, female, male
4 autores
- Raghu Sarath Punukollu
- Arun Kumar Chadalawada
- Kalyani Siddabattuni
- Naga Tejaswi Gogineni · autor de correspondencia
Resumen
El texto original del estudio, en el idioma en que se publicó.
Ethnopharmacological relevance
Withania somnifera (L.) Dunal (WS) and Abelmoschus esculentus (L.) Moench (AE) are known as Ashwagandha and Okra, respectively, important herbs in traditional medicine for their diverse therapeutic values. WS root is an adaptogen that relieves stress and anxiety and promotes sleep. AE fruit or Okra is widely consumed as a vegetable and is traditionally used to treat diabetes, gastric irritations, ulcers, and obesity.
Aim of the study
The present randomized, double-blind, placebo-controlled study aimed to establish a proof-of-concept evaluating the efficacy and tolerability of a proprietary blend of standardized extracts of WS root and AE fruit, CL18100F4 in relieving constipation and improving quality of life in adults.
Materials and methods
Forty-eight male and female participants (age: 25-60 years) with functional constipation (following Rome-III criteria) were randomized into placebo, 300 or 500 mg of CL18100F4 groups, and supplemented for fourteen consecutive days.
Results
CL18100F4 supplementation significantly (p < 0.0001) reduced the Patient Assessment of Constipation-Symptoms (PAC-SYM), Patient Assessment of Constipation-Quality of Life (PAC-QOL), and Gastrointestinal Symptom Rating Scale (GSRS) scores. CL18100F4 supplementation improved sleep quality and reduced stress (p < 0.0001). At the end of the study, CL18100F4-500 subjects showed significant increases in serum serotonin, gastrin, and interleukin-10 and decrease in interleukin-6 and cortisol levels. Participants' hematology, total blood chemistry, vital signs, and urinalysis parameters were within the normal ranges. No adverse events were reported.
Conclusions
This short-duration, single-site clinical investigation demonstrates that CL18100F4 supplementation is tolerable, helps relieve constipation, reduces stress, and improves gastrointestinal function, sleep quality, and general wellness in adults.
Trial registration
Clinical Trials Registry- India (CTRI/2020/11/029320); Registered on 24/11/2020. Available at: http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=49391&EncHid=&userName=CL18100F4.
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