ABSTRACT
OBJECTIVES: Abha Guggulu (AG) is a traditional Ayurvedic herbal formulation used for treating joint disorders and bone fractures. Individually, the ingredients are known for their promising anti-inflammatory and rejuvenating actions. The present study attempts to explore the anti-arthritic potential of AG through an exploratory clinical trial. METHODS: The study was conducted using a quasi-experimental model. The clinical trial has been registered in Clinical Trials Registry of India (registration number: CTRI/2019/09/021354). Osteoarthritis patients of both genders (n=12, 40-70 years age group), meeting the inclusion/exclusion criteria, were recruited in the single arm study. AG was administered in tablet form in a dose of 1.5 g, twice daily. The WOMAC score was used as a primary outcome measure. The WOMAC scale of patients was recorded on 0th, 15th and 30th days of treatment. RESULTS: At the end of treatment, there was a significant difference in the scores of the outcome measure. As per WOMAC total score, participants were significantly improved (p=0.002) after consuming the drug for 1 month. CONCLUSIONS: Overall, the data indicates significant improvement of subjects in both scales and objective measures used for assessment purposes. There were no adverse drug reactions reported during the trial. AG may be used as a safe and effective supplement to reduce symptoms of osteoarthritis. The clinical efficacy of the formulation might be mediated through the synergistic blend of herbal bioactive compounds from AG.
Subject(s)
Osteoarthritis , Female , Humans , Male , Commiphora , Osteoarthritis/drug therapy , Plant Extracts/adverse effects , Treatment Outcome , Adult , Middle Aged , AgedABSTRACT
BACKGROUND: Swarnabhasma (calcined gold) is a famous ancient Ayurvedic medicine. However, its detail characteristic investigations are very limited. OBJECTIVE: Herein, investigation of swarnabhasma is demonstrated using ancient and ultramodern techniques to understand the physicochemical nature of this drug, and to understand whether the mercury [Parada] used during preparation method marks its presence in swarnabhasma. MATERIALS AND METHODS: The investigated swarnabhasma was prepared by repeated incinerations of Au-Hg-Lemon juice amalgamation and sulphur. The bhasma was tested by all traditional tests of rasashastra. It was characterized by X-ray diffraction (XRD), Field Emission Scanning Electron Microscope (FE-SEM), Field Emission Transmission Electron Microscopy (FE-TEM), Inductively Coupled Plasma Atomic Emission Spectroscopy (ICP-AES), Energy Dispersive X-ray Fluorescence (EDXRF), Fourier Transform Infrared Spectroscopy (FTIR), and gravimetric analysis. RESULTS: Traditional tests of rasashastra were complied by the sample. XRD confirms that swarnabhasma consists of principally pure gold at nanoscale. FE-SEM showed agglomerated particles. FE-TEM showed that swarnabhasma contains highly crystalline nanostructured gold comprised with spherical gold nanoparticles of size, 5-20 nm. ICP-AES exhibited absolute absence of Hg and presence of Au, Si, Ag, Al, Ca, Cu, Fe, K, Mg, Mn, Na, P, Sr, Ti, and Zn. EDXRF confirmed the absence of mercury and confirmed the presence of Au, Si, Zr, Nb, S, Cl, K, Ca, Fe, and Ni. FTIR confirmed presence of water molecules adsorbed over surface of bhasma. Gravimetric analysis confirmed presence of 95% gold. CONCLUSION: Nano-structuring of gold enhances the surface area as well as activity. The present investigation shows that the entire process from rasashastra confers the unique nanostructure to gold and same is responsible for its medicinal potential. This nanomedicine is highly stable, which is specified as niruttha and apunarbhava in rasashastra.
ABSTRACT
Bioavailability of the well-known Ayurvedic drug Swarnabhasma (gold bhasma or calcined gold) is unknown. It is orally administered either sublingually or directly with various Anupanas like black pepper powder (Piper nigrum Linn.) and cow ghee in the dose range of 15-240 mg by Ayurvedic physicians. Study of bioavailability of Swarnabhasma is necessary as this metal-derived drug is administered for long duration for rejuvenation. The pilot study was carried out in healthy human male participants to assess bioavailability of Swarnabhasma in three doses, viz. 30 mg plain sublingual, 30 mg oral dose mixed with black pepper powder (250 mg) and cow ghee (2.5 gm); and 240 mg oral dose mixed with black pepper powder (250 mg) and cow ghee (2.5 gm). Blood samples were withdrawn at 0, 1, 2 and 4 h after administration of dose. Estimation of gold levels in blood was carried out by inductively coupled plasma mass spectrometry (ICP-MS). Results show that gold is absorbed in traces from single dose of Swarnabhasma. Maximum concentration of gold was bioavailable from 30 mg sublingual dose with Cmax 0.983 µg/L at 2 h (Tmax). Oral dose of 30 mg Swarnabhasma mixed with black pepper powder and ghee showed faster absorption with Tmax at 1 h and Cmax 0.867 µg/L, and 240 mg dose with black pepper and ghee showed Cmax 0.668 µg/L and Tmax at 2 h.
