SCIENTIFIC EVIDENCE SUPPORTING THE EFFICACY OF HERBAL IGNITE FOR HER PRODUCT

EXECUTIVE SUMMARY

 

The natural ingredients described below have a long history of traditional use and have demonstrated their safety and efficacy in human clinical trials. A brief summary of some evidence available for each ingredient is described below.

In summary, the key ingredients with the highest level of evidence from human clinical trials are:

• Milk Thistle and Broccoli sprouts (sulforaphane) has been shown in multiple clinical trials to support liver health, detoxification and hormone balance.
• Chaste Tree and Lemon Balm have been shown in multiple human clinical trials to reduce the symptoms of PMS.
• Withania/Ashwaganda as the extract KSM66 has been shown in multiple trials to support sexual and cognitive function as well as to reduce the negative effects of stress.
• Cinnamon and chromium have been found in multiple clinical trials to support blood sugar balance.

 

FURTHER INGREDIENT INFORMATION

Milk Thistle
Milk Thistle (Silybum marianum) is a well-known herb that contains bioactive compounds collectively referred to as silymarin. Milk Thistle has a long history of traditional use for supporting liver health and healthy detoxification and this use has been verified by modern scientific research. Milk Thistle has been tested in multiple human trials in relation to liver health and protection. It has been tested for both alcoholic and non-alcoholic liver diseases, viral hepatitis and as a liver protective agent during chemotherapy and from both chemical and mushroom poisoning. The multiple clinical studies been subjected to a recent systematic review and meta-analysis. The authors included 8 clinical studies and found that Milk Thistle statistically reduced liver enzymes (found to be elevated during liver stress or damage) (Kalopitas et al., 2021).

 

Broccoli Sprout
Broccoli sprout powder is a source of sulforaphane which induces the NRF2 transcription factor. Inducing NRF2 has wide ranging benefits for health including enhances cellular antioxidant defences and supporting healthy detoxification which can help with hormone balance through the detoxification of oestrogen metabolites (Houghton, 2019).

 

Chaste Tree (Vitex-agnus castus)
Vitex agnus-castus is also known as Chaste Tree, or Chasteberry. It has a long history of use and is primarily used today by modern herbalists to alleviate the symptoms of premenstrual syndrome. Vitex agnus-castus has outperformed placebo in numerous clinical trials, and has been shown to be effective at reducing hot flashes, bloating, irritability, sleep disturbances, depressions, various mood disorders and even cramping associated with premenstrual syndrome. It’s effect on reducing PMS was confirmed in a recent systematic review with meta-analysis that found patients taking Chaste Tree were 2.5 times as likely to experience remission of their PMS symptoms compared to placebo (Csupor et al., 2019).

 

KSM 66 Ashwaganda (Withania somnifera)
Ashwagandha (Withania somnifera) is an herb used in Ayurvedic medicine, the traditional medicine of India. Its root has a horsey smell (in Sanskrit, ashva means “horse” and gandha means “smell”) and is said to confer the strength and virility of a horse. Various parts of the plant are used, but the most common in supplements is an extract of its roots.

KSM-66 is a branded and clinically trialled extract of Ashwaganda and is considered the “worlds best Ashwaganda”

KSM-66 has the highest concentration of all major full-spectrum root extracts available on the market today. In a recent study, it was found to have the highest bioavailability.

KSM-66 has the most extensive set of research studies and clinical trials. We have 24 studies: 12 published studies, 6 additional studies completed and in peer review and 6 ongoing studies.

KSM-66 Ashwagandha has been shown in clinical trials to:
(1) Reduce stress, anxiety, cortisol levels, and stress-related food cravings (Chandrasekhar et al., 2012)
(2) Enhance memory and cognition (Choudhary et al., 2017)
(3) Increase endurance, strength, muscle size and muscle recovery rate (Wankhede et al., 2015)
(4) Improve sexual function in women (Dongre et al., 2015)

 

Lemon Balm (Melissa officinalis)
Lemon Balm is a herb with a long history of traditional use as a calming herb for both the gut and for states of stress and anxiety. It can also improve cognition when people are under stress and has been shown in clinical trials to be helpful for PMS.

A randomised double blind clinical trial published in 2015 examined the effectiveness of lemon balm taken for three months on the intensity of PMS symptoms in 50 high school women. It was found that lemon balm led to a significant reduction in PMS symptoms (P<0.001) as measured by the Premenstrual symptoms screening tool (Akbarzadeh et al., 2015).

In a follow-up to the above study, a recent clinical trial looking at the mental health of women with PMS, Lemon balm was given compared to placebo to 50 adolescents with PMS for a period of 3 months. It was found that the women receiving lemon balm had statistically significant (P<0.001) reductions in anxiety and sleep disorders (Heydari et al., 2018).

 

Cinnamon (Cinnamomum sp)
Cinnamon has a very long and prestigious history of traditional therapeutic use. It has a long history of use for blood sugar regulation from China, Korea, Russia and India. Scientific research has confirmed cinnamon’s ability to help regulate blood sugar levels. Cinnamon has been subjected to multiple trials that have involved blood sugar control that investigated its utility in metabolic syndrome, diabetes and in polycystic ovary syndrome (PCOS).

A recent systematic review with meta-analysis from 2020 compared 5 clinical trials investigating the use of cinnamon in women with PCOS. It was found that cinnamon significantly reduced fasting blood sugar, insulin and insulin resistance (Heydarpour et al., 2020).

 

Chromium
Chromium is an essential mineral involved in blood glucose metabolism and maintaining insulin sensitivity. Chromium intake from food is dependant on soil levels and some soils of Australia and New Zealand are known to be deficient in chromium. Deficiency of chromium is known to lead to blood sugar dysregulation and weight management issues.

Chromium has been extensively tested for blood sugar control as a supplement in many clinical trials and these have been subjected to systematic review and meta-analysis. A recent review of 28 studies investigating chromium in type 2 diabetes found that chromium supplementation significantly reduced fasting blood sugar, serum insulin, insulin resistance and HBA1C levels (Asbaghi et al., 2020).

 

Calcium-D-Glucarate
Calcium-D-Glucarate is known to be a β-glucoronidase inhibitor. β-glucoronidase is an enzyme produced by the gut microbiome known to reduce the process of glucuronidation which is a detoxification process. Calcium-D-glucarate is therefore thought to be beneficial for hormone balance as it has the effect of preventing the breakdown and reabsorption of oestrogen metabolites that have been excreted by the liver.

 

REFERENCES

• Akbarzadeh, M., Dehghani, M., Moshfeghy, Z., Emamghoreishi, M., Tavakoli, P., & Zare, N. (2015). Effect of Melissa officinalis Capsule on the Intensity of Premenstrual Syndrome Symptoms in High School Girl Students. Nursing and Midwifery Studies, 4(2), e27001. https://doi.org/10.17795/nmsjournal27001
• Asbaghi, O., Fatemeh, N., Mahnaz, R. K., Ehsan, G., Elham, E., Behzad, N., Damoon, A.-L., & Amirmansour, A. N. (2020). Effects of chromium supplementation on glycemic control in patients with type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials. Pharmacological Research, 161, 105098. https://doi.org/10.1016/j.phrs.2020.105098
• Chandrasekhar, K., Kapoor, J., & Anishetty, S. (2012). A prospective, randomized double-blind, placebo-controlled study of safety and efficacy of a high-concentration full-spectrum extract of ashwagandha root in reducing stress and anxiety in adults. Indian Journal of Psychological Medicine, 34(3), 255–262. https://doi.org/10.4103/0253-7176.106022
• Choudhary, D., Bhattacharyya, S., & Bose, S. (2017). Efficacy and Safety of Ashwagandha (Withania somnifera (L.) Dunal) Root Extract in Improving Memory and Cognitive Functions. Journal of Dietary Supplements, 14(6), 599–612. https://doi.org/10.1080/19390211.2017.1284970
• Csupor, D., Lantos, T., Hegyi, P., Benkő, R., Viola, R., Gyöngyi, Z., Csécsei, P., Tóth, B., Vasas, A., Márta, K., Rostás, I., Szentesi, A., & Matuz, M. (2019). Vitex agnus-castus in premenstrual syndrome: A meta-analysis of double-blind randomised controlled trials. Complementary Therapies in Medicine, 47, 102190. https://doi.org/10.1016/j.ctim.2019.08.024
• Dongre, S., Langade, D., & Bhattacharyya, S. (2015). Efficacy and Safety of Ashwagandha (Withania somnifera) Root Extract in Improving Sexual Function in Women: A Pilot Study. BioMed Research International, 2015, 284154. https://doi.org/10.1155/2015/284154
• Heydari, N., Dehghani, M., Emamghoreishi, M., & Akbarzadeh, M. (2018). Effect of Melissa officinalis capsule on the mental health of female adolescents with premenstrual syndrome: a clinical trial study. International Journal of Adolescent Medicine and Health, 31(3). https://doi.org/10.1515/ijamh-2017-0015
• Heydarpour, F., Hemati, N., Hadi, A., Moradi, S., Mohammadi, E., & Farzaei, M. H. (2020). Effects of cinnamon on controlling metabolic parameters of polycystic ovary syndrome: A systematic review and meta-analysis. Journal of Ethnopharmacology, 254, 112741. https://doi.org/10.1016/j.jep.2020.112741
• Houghton, C. A. (2019). Sulforaphane: Its “Coming of Age” as a Clinically Relevant Nutraceutical in the Prevention and Treatment of Chronic Disease. Oxidative Medicine and Cellular Longevity, 2019, 2716870. https://doi.org/10.1155/2019/2716870
• Kalopitas, G., Antza, C., Doundoulakis, I., Siargkas, A., Kouroumalis, E., Germanidis, G., Samara, M., & Chourdakis, M. (2021). Impact of Silymarin in individuals with nonalcoholic fatty liver disease: A systematic review and meta-analysis. Nutrition (Burbank, Los Angeles County, Calif.), 83, 111092. https://doi.org/10.1016/j.nut.2020.111092
• Wankhede, S., Langade, D., Joshi, K., Sinha, S. R., & Bhattacharyya, S. (2015). Examining the effect of Withania somnifera supplementation on muscle strength and recovery: a randomized controlled trial. Journal of the International Society of Sports Nutrition, 12, 43. https://doi.org/10.1186/s12970-015-0104-9