Evaluation of the efficacy and safety of a herbal formulation for rheumatoid arthritis - A non-inferiority randomized controlled trial.

ETHNOPHARMACOLOGICAL RELEVANCE: Rheumatoid arthritis (RA) is a diverse disease characterized by a variable, progressive course of articular and extra-articular symptoms that are linked with pain, disability, and mortality. The exact cause of rheumatoid arthritis is still being investigated, and there is no cure for this debilitating, persistent, painful disease. Qurs-e-Mafasil, a herbal Unani preparation, is regarded as a potent treatment for Waja'al-Mafasil, a condition clinically similar to rheumatoid arthritis, but scientific evidence is scarce. AIM OF THE STUDY: This study aimed to assess the non-inferiority of Qurs-e-Mafasil compared to celecoxib in the treatment of patients with rheumatoid arthritis. MATERIALS AND METHODS: This randomized controlled trial was conducted on seventy patients diagnosed with rheumatoid arthritis between the ages of 35 and 55 years. The participants were randomly allocated in a ratio of 3:2, with 42 participants in the test group and 28 participants in the control group. The test group was administered 2 tablets (each having 500 mg) of Qurs-e-Mafasil, while the control group was administered 1 capsule of Celecoxib 100 mg. Both medications were delivered for four weeks. The primary outcome measure was European League Against Rheumatism (EULAR) response criteria based on Disease Activity Score-28 (DAS28) assessed before and after therapy, whereas the secondary outcome measure was the change in joint pain severity as determined by a 100 mm Visual Analog Scale (VAS) at baseline and each follow-up. The safety of the interventions was evaluated based on adverse event monitoring at each follow-up and laboratory tests including hemogram, Liver Function Tests (LFTs), Kidney Function Tests (KFTs), and a complete urine examination performed at baseline and after four weeks of treatment. RESULTS: The per-protocol analysis was done on 50 participants (30 in test group and 20 in control group) who completed the study duration. Thus, at the conclusion of the trial, participants in the test and control groups had either a moderate or no response based on EULAR response criteria. The odds ratio for no response versus moderate response between the test and the control groups was 0.71 (95% CI: 0.20-2.55) with p = 0.744. Moreover, the observed mean differences in VAS scores between the test and the control groups at 1st, 2nd, 3rd, and final follow-up were -0.33 (95% CI: -6.65 to 5.99, p = 0.916), 0.50 (95% CI: -5.63 to 6.63, p = 0.870), 2.42 (95% CI: -2.95 to 7.78, p = 0.370), and 3.00 (95% CI: -1.82 to 7.84, p = 0.219), respectively. CONCLUSIONS: The differences in primary and secondary outcomes between the two groups indicate that Qurs-e-Mafasil, a herbal Unani formulation containing Zingiber officinale Roscoe rhizome, Colchicum luteum Baker root, Piper nigrum L. fruit, and Withania somnifera (L.) Dunal. root, is comparable to celecoxib in the treatment of rheumatoid arthritis.

A comprehensive review on Trigonella foenum-graecum L. with special reference to Unani medicine.

Trigonella foenum-graecum L., commonly known as Hulba or Methi in Unani medicine, is an annual self-pollinating plant belonging to the Leguminosae family. It has been utilized for centuries to treat a wide range of diseases, and modern research has supported its traditional medicinal claims. In this study, the authors have conducted manual and online searches to gather and summarize the scientific literature on Hulba. This article seeks to underscore the potential of Hulba in addressing a variety of health conditions as identified by esteemed classical Unani scholars, as well as to investigate its phytochemistry and pharmacological properties in contemporary medicine. The authors have utilized electronic databases, such as PubMed, Science Direct, DOAJ, Google Scholar, and Ayush Research Portal to filter published material. According to the gathered literature, Unani physicians have consistently recommended Hulba seeds for a variety of ailments, such as indigestion, flatulence, colitis, arthritis, backache, paralysis, headaches, common cold, cough, bronchial asthma, diabetes mellitus, vitiligo, and pityriasis. Additionally, the seeds and green leaves of Hulba contain several chemical constituents, such as alkaloids, flavonoids, steroids, saponins, and amino acids. Furthermore, several pharmacological studies have demonstrated that Hulba possesses various properties, including antidiabetic, antispasmodic, hypolipidemic, immunological, antibacterial, anthelmintic, anti-inflammatory, analgesic, and antioxidant activities. Based on the available evidence, it can be concluded that Hulba has been effectively used in Unani medicine for treating a wide range of diseases. Unani scholars have extensively documented its pharmacological properties, which have been supported by modern research studies. However, further research is necessary to validate some of the claims made in traditional medicine using scientific parameters.

The Efficacy and Safety of Herbal Unani Formulations in Chronic Plaque Psoriasis: A Single-arm Clinical Trial.

Background: Despite there being advanced treatment options, psoriasis remains an incurable and recurring disease. Noteworthy scholars of Unani (Greco-Arab) medicine have proposed many drugs and formulations for psoriasis but the scientific evidence on the same is scarce. Hence, trial formulations were selected for the study. Primary Study Objectives: This study was designed to evaluate the efficacy and safety of two herbal Unani formulations, Ma΄jun Mundi and Qairuti Karnab, in the management of chronic plaque psoriasis (CPP). Methods/Design: This open-label, single-arm clinical trial was conducted on 33 participants, of whom 30 completed the 12-week treatment course. Setting: This study was conducted at the Central Research Institute of Unani Medicine (CRIUM), Hyderabad, Telangana, India, from 01 August 2018 to 25 May 2019. Participants: Participants of any gender aged 18 to 65 years with clinically diagnosed CPP and psoriasis area severity index (PASI) ≥ 10% were included in the trial. Interventions: The participants received 5 g of Ma΄jun Mundi (a semisolid preparation) orally, twice daily with water, followed by the topical application of Qairuti Karnab (a homogenous paste) to cover the lesions over 12 weeks. Outcome Measures: The primary outcome measure was the change in PASI determined pre- and post-trial in terms of mean and percentage reduction. Secondary outcome measures were changes in patient global assessment (PGA) on a 100 mm visual analog scale, investigator global assessment (IGA) on a 6-point scale, and subjective parameters including erythema, induration, scaling, and itchiness. Results: The analysis revealed a significant reduction in the PASI score, with 12 subjects (40%) achieving PASI 75 and 3 subjects (10%) achieving PASI 90. Significant improvements were also observed in secondary outcome measures with no adverse events. Conclusion: The findings of the study indicate that the trial formulations exhibit a notable anti-psoriatic effect without any adverse effects. The formulations are worthy of further evaluation as an alternative treatment for CPP.

A non-inferiority randomized controlled clinical trial comparing Unani formulations and PUVAsol in non-segmental vitiligo.

OBJECTIVES: Greco-Arab medicine is an ancient system of medicine with greater treasure on therapeutics of vitiligo. The trial Unani formulations have not been scientifically explored for their safety and efficacy, but have been repeatedly prescribed by the great Unani physicians in the management of Baras (vitiligo). Hence, these interventions were selected for the trial. METHODS: In this randomized, controlled, open-label clinical trial, 82 participants with non-segmental vitiligo aged 18-40 years were block randomized to either receive Unani interventions or control for 16 weeks. Out of 82 participants, 42 were randomized to the Unani group and 40 were randomized to the control group. The primary outcome measure was change in vitiligo area scoring index (VASI), which was assessed on weeks 4, 8, 12 and 16. The secondary outcome measures included the patient's global assessment on VAS and investigator's global assessment based on photographic evaluation at baseline and after the treatment. Safety parameters included hemogram, LFTs, RFTs, CXR, ECG, urine, and stool examinations, which were evaluated at baseline and after the treatment. RESULTS: The per-protocol analysis was done on 30 participants in each group and the response in Unani group was not inferior to those receiving control group. The mean ± SD of vitiligo area scoring index (VASI) decreased from 4.09 ± 2.87 and 5.50 ± 5.73 at baseline to 3.13 ± 2.20 and 4.29 ± 4.95 at the end of the trial in both the Unani and control groups respectively. CONCLUSIONS: The study inferred that both the interventions are equally effective and well-tolerated in patients with non-segmental vitiligo.

Treatment of chronic plaque psoriasis with herbal Unani formulations: A randomized control trial of efficacy and safety.

ETHNOPHARMACOLOGICAL RELEVANCE: Psoriasis, despite modern therapeutic options, is incurable and recurrent. In Unani (Greco-Arab) medicine, many medications and formulations have been prescribed by eminent scholars for conditions clinically similar to psoriasis, though empirical evidence is sparse. Hence, the experimental formulations ItrifalShahtra and MarhamHina were chosen to be compared to the standard therapies PUVAsol and petrolatum for their safety and efficacy. MATERIALS AND METHODS: This open-label, randomized control clinical trial was conducted on 66 male and female participants with chronic plaque psoriasis, ranging in age from 18 to 65 years. In each group, 33 participants were block randomized to either receive Unani formulations or control drugs for 12 weeks. The Unani group received oral Itrifal Shahtra (a semisolid paste) and topical MarhamHina (an ointment) twice daily, and the control group received oral 8-methoxypsoralen and topical petroleum jelly for local application. Participants of both groups were advised to get daily sunlight exposure for 5-15 min. The primary outcome measure was the change in psoriasis area and severity index (PASI) assessed at each visit. Secondary outcome measures were patient global assessment on a 100 mm VAS applied at baseline and after 12 weeks of treatment and change in subjective parameters including erythema, induration, scaling, and itching, assessed on a 5-point scale at every visit. Hemogram, LFTs, RFTs, CXR, ECG, urine, and stool tests were all assessed at baseline and after treatment for the safety of the drugs. RESULTS: The per-protocol analysis was done on 25 participants in each group. The mean ± SD of the psoriasis area severity index (PASI) significantly decreased from 27.88 ± 12.01 and 23.61 ± 9.79 at baseline to 5.01 ± 4.59 and 9.85 ± 7.16 after completion of the trial therapies in both Unani and control groups, respectively. Also, the test formulations outperformed the control drugs on clinically significant endpoints, PASI 50 and PASI 75, with all 25 participants achieving PASI 50 and 76% achieving PASI 75. CONCLUSION: The trial formulations, ItrifalShahtra and MarhamHina may be superior to control drugs PUVAsol and petrolatum in terms of safety, efficacy, and tolerability in the treatment of chronic plaque psoriasis. Thus, the Unani formulations may further be evaluated in a well-designed multicentric superiority trial with an adequate sample size.

The biflavonoid, amentoflavone degrades DNA in the presence of copper ions.

Previous reports from this laboratory have shown that flavonoids including apigenin are capable of inducing oxidative DNA cleavage in the presence of copper ions. In the present report, we have examined the ability of amentoflavone, a biflavonoid which is a dimer of apigenin, to catalyze the degradation of DNA. Amentoflavone was found to degrade calf thymus DNA in the presence of Cu(II) at a rate almost twice that of apigenin. Amentoflavone was also shown to reduce Cu(II) to Cu(I) and to generate hydroxyl radicals in the presence of copper ions. In the presence of Cu(II), the absorption spectrum of amentoflavone undergoes a shift and a quenching effect indicating that the biflavonoid is capable of binding to copper ions. Amentoflavone and apigenin were isolated from Cycas rumphii and Trifolium alexandrinum, respectively. The results are discussed in relation to the putative chemopreventive mechanism of amentoflavone.

Anti fi larial potential of the fruits and leaves extracts of Pongamia pinnata on cattle filarial parasite Setaria cervi.

The effect of aqueous and alcohol extracts of the fruits and leaves of Pongamia pinnata (Linn.) Merr. (Syn. Pongamia glabra Vent, leguminosae) on the spontaneous movements of both the whole worm and the nerve-muscle preparation of Setaria cervi and on the survival of micro fi lariae in vitro was studied. The aqueous and alcohol extracts of fruits and the alcohol extract of leaves caused an inhibition of spontaneous movements of the whole worm and the nerve-muscle preparation of S. cervi. The initial stimulatory effect was not observed with the aqueous extract of fruits on the nerve-muscle preparation. The concentration required to inhibit the movements of the whole worm preparation was 250 micro g/mL for aqueous, 120 micro g/mL for alcohol extract of fruits and 270 microgram/mL for alcohol extracts of the leaves. The concentrations of P. pinnata extracts required to produce an equivalent effect on the nerve-muscle preparation were 25 micro g/mL, 5 micro g/mL and 20 micro g/mL, respectively, suggesting a cuticular permeability barrier.

Effect of khat, its constituents and restraint stress on free radical metabolism of rats.

The leaves of khat (Catha edulis) are found to have stimulating and pleasurable effect and are chewed habitually by people of East Africa and Arabian Peninsula. Due to various toxic and psychostimulative effect of khat the present study was undertaken to evaluate the effect of intragastric khat alone or its major constituents flavonoids/alkaloids administration and before and after 4 h of immobilization stress in terms of alteration of free radical scavenging/metabolizing enzymes, uric acid and glucose in rats. Oral khat, alkaloid administration or 4 h restraint stress resulted in the decrease of the circulating levels of superoxide dismutase, catalase, glutathione-S-transferase and glucose with enhanced uric acid concentrations as compared with control rats. Oral treatment with flavonoid fraction of khat was found to enhance the activities of GST and catalase but showed no effect on SOD while the level of glucose was decreased and uric acid increased. The levels of these biochemical parameters were more altered in post stress khat/alkaloid treated rats than pre stress khat/alkaloid treated rats. The alteration in the levels of SOD, GST, catalase and uric acid in the pre stress khat treated rats were comparable with that of khat alone, except the level of glucose which was further decreased in pre stress khat treated rats. The flavonoid fraction of khat reduced the stress induced oxidative stress in terms of above mentioned biochemical parameters. The present study suggests that khat alone or khat/alkaloid consumption preceding stress may significantly decrease the levels of free radical metabolizing/scavenging enzymes and glucose leading to enhanced free radical concentration and toxicity of khat, which could be due to its alkaloid fraction as flavonoids were found to show antioxidant properties for oxidative stress generated during restraint stress.