Allergic Rhinitis is a hypersensitivity disorder that has become quite prevalent these days, causing strain on general health and economy. A new herbal formulation (Aller-7), made from extracts of seven medicinal plants, has proved to be an effective and safe remedy, with anti-inflammatory properties. In this study, the researchers determined whether Aller-7 adversely affected different body parts such as mouth, skin, and eyes, specifically after regularly using it for three months. To determine the level of toxicity, varied doses of the medicine were used. It was found that even a high dose of more than 1,000 mg/kg body weight did not trigger any adverse reactions.
Allergies are a big financial healthcare burden all over the world. Allergic rhinitis is highly prevalent globally. The symptoms disrupt the daily activities and productivity of the patients. Therapeutic options or natural remedies that are currently available are not very effective. Besides, they are associated with several side-effects. The new anti-allergic medicine, Aller-7, is made by combining stoichiometric portions of seven Indian plants, namely, Phyllanthus emblica (fruit), Terminalia chebula (fruit), Terminalia bellerica (fruit), Albizia lebbeck(bark), Zingiber officinale (rhizome), Piper longum (fruit), and Piper nigrum (fruit). Thus, Aller-7 is a significant formulation, in terms of scientifically proven efficacy and safety. It is known to boost immunity through anti-inflammatory action. This study further confirmed the already well-established safety profile of Aller-7, in case of high dosage and long-term usage, too. Toxicity experiments were conducted to check for any oral and dermal side-effects and possible irritation to the skin and eye.
- Aller-7 was administered in different dosages, either orally or through topical application, on experimental rats/rabbits employed for this study. The animals were segregated into treatment and control groups.
- The tests conducted determined acute oral toxicity, acute dermal toxicity, acute dermal irritation, acute eye irritation, and repeated 90-day oral toxicity.
- Observations were made to determine mortality and clinical changes or adverse symptoms, at stipulated time-periods, on the day of administration and for the subsequent 14 days. The animals were sacrificed to conduct pathological/histological estimations, as per requirements of this study.
- The overall results indicated that clinical symptoms or pathology or weight gain did not induce any risk of mortality or significant abnormality. The oral test established safe dose at >5,000 mg/kg body weight for Aller-7, while the safe dose was >2,000 mg/kg body weight for Aller-7, as per dermal test.
- The skin tests did not report any redness or swelling. Aller-7 proved to be non-irritant on rabbit skin.
- Slight redness in the eyes, reported at one hour after application, disappeared within 24 hours, showing minimal irritation on the eyes of rabbits.
- The repeated dose up to 1,000 mg/kg for 90 days showed no mortality, neurotoxicity, or disturbances to the eyes. There were no alterations in body weight or food intake. There was no change in the blood, biochemical or pathological parameters. Hence, this was termed the NOAEL-no observed adverse effect level of Aller-7 in rats.
This study has confirmed the upper limits of safe dose. However, to apply as a clinical formulation, the exact dose in each application should be calculated. Although the efficacy of Aller-7 has been proved in humans, extensive clinical trials in humans are essential to verify its safety parameters, since this data on safety pertains to animal studies.
This study firmly established the broad-spectrum potential of Aller-7 in treating allergic rhinitis, regardless of high dosage and longer duration of administration. The mechanism of the action of Aller-7 includes events of mast cell stabilization, enzyme inhibition, and antihistaminic activity: these reduce symptoms of nasal congestion and sneezing. For overall control of allergic rhinitis, avoiding allergens is essential. Several conventional and new antihistaminic drugs include chlorpheniramine, fexofenadine, cetirizine, and mast cell stabilizers like cromoglycate, and intranasal corticosteroids. But, they are either not effective enough or are associated with side-effects like sedation, fatigue, anxiety, irritation, and bleeding. Aller-7 is the first anti-allergic entity devoid of such adverse effects while efficiently relieving allergic rhinitis.
For More Information:
Safety of a Novel Botanical Extract Formula for Ameliorating Allergic Rhinitis
Publication Journal: Toxicology Mechanisms and Methods, 2005
By A. Amit; A. J. Joshua
From the Natural Remedies Research Center, Bangalore, India
*FYI Living Lab Reports Are Summaries of the Original Research.