The objective of the study was to assess the safety and efficacy of Roop Mantra Cucumber Ayurvedic Medicinal Face Wash in subjects with acne, facial scars, pimples, blemishes, dull skin and dry skin. Methods: This was a single-center, open-label, non-randomized post-marketing surveillance study with 120 subjects. Subjects were selected on the basis of inclusion criteria. The study included three scheduled clinical visits on days 0 (screening and baseline visit), 15 (follow-up visit), and 30 (final visit). Following an assessment of baseline data, all subjects were given Roop Mantra Cucumber Ayurvedic Medicinal Face Wash for 30 days. The efficacy of Roop Matra Cucumber Ayurvedic Medicinal Face Wash was determined by measuring changes in parameters such as skin characteristics, skin appearance, and Global Acne Assessment (GAA) score. Product safety was assessed by determining local intolerance and adverse effects of Roop Mantra Cucumber Ayurvedic Medicinal Face Wash. Results: The results of the study showed that applying Roop Mantra Cucumber Ayurvedic Medicinal Face Wash for 30 days significantly improved skin’s characteristic and appearance. Roop Mantra Cucumber Ayurvedic Medicinal Face Wash was also found to be dermatologically well tolerated and had no negative impacts over the course of the study. Conclusion: The polyherbal Roop Mantra Cucumber Ayurvedic Medicinal Face Wash was found to be very safe and effective in reducing acne, pimples, blemishes, and skin dryness with improved skin texture and appearance. Roop Mantra Cucumber Ayurvedic Medicinal Face Wash is therefore a clinically feasible and safe alternative for treating the aforementioned skin conditions.
Objectives: The objective of the study was to evaluate the efficacy and safety of a polyherbal Roop Mantra Ayurvedic Medicinal Cream in subjects with acne, facial scars, pimples, blemishes, dull and dry skin. Methods: This was a 60-day, single-centre, open-labelled, non-randomized phase-IV surveillance study with 120 subjects. Subjects were selected based on the study's inclusion criteria. The study included three scheduled clinical visits on days 0 (screening and baseline visit), 30 (follow-up visit), and 60 (final visit). Following an evaluation of baseline data, all subjects were given Roop Mantra Ayurvedic Medicinal Cream for 60 days. The primary outcome of the study was to assess the efficacy of Roop Mantra Ayurvedic Medicinal Cream based on changes in parameters such as skin texture, skin health, global acne assessment parameters and an investigator assessment scale. The secondary outcome of the study was the determination of local intolerance and adverse effects to Roop Mantra Ayurvedic Medicinal Cream . Results: The study findings revealed that the use of Roop Mantra Ayurvedic Medicinal Cream for 60 days improved skin texture and appearance while significantly reducing acne, pimples, blemishes, and skin dryness. Roop Mantra Ayurvedic Medicinal Cream was likewise dermatologically well tolerated and did not cause any adverse effects during the study period. Conclusion: Roop Mantra Ayurvedic Medicinal Cream showed highly satisfactory results in terms of skin texture, skin appearance and general acne parameters without having any adverse effects on the skin. Given the positive outcomes, Roop Mantra Ayurvedic Medicinal Cream is clinically effective and safe alternative for treating various skin problems.
Constipation is a common gastrointestinal complaint among 16% of the world's population. Several conventional treatments are recommended; however, these sometimes do not provide satisfactory results for many patients or cause unpleasant side effects. In this context, Ayurvedic medicine can be an alternative, cost-effective and satisfactory treatment for constipation. Hence, this clinical study aimed to evaluate the efficacy and safety of an Ayurvedic PetSaffa formulation in subjects with functional constipation. Design, Setting, Participants and Intervention: This open-label, non-randomized clinical study was conducted to evaluate the safety and efficacy of an Ayurvedic PetSaffa formulation in healthy volunteers with functional constipation. Subjects were selected based on inclusion and exclusion criteria. Participants received PetSaffa granules for 21 days. Outcome parameters of the study, including frequency of bowel movements, constipation score, constipation symptoms, gas, acidity, and serum level of SGPT, were evaluated at screening and after 21 days of treatment. Results: A total of 120 participants completed the 21-day treatment. At the end of the treatment period, all clinical outcomes, including frequency of bowel movement and constipation score, were significantly (p<0.001) improved. The analysis of constipation symptoms' frequencies and severity also significantly (p<0.001) improved without any significant adverse effects. Additionally, PetSaffa granules also reduced gas and acid symptoms. As part of the safety study, serum levels of SGPT were within the normal range before and after treatment. Conclusion: The study intervention, PetSaffa granules, significantly improved bowel movements, gas and acidity symptoms without causing any adverse effects. Therefore, the Ayurvedic PetSaffa granules are a clinically effective and safe alternative for the treatment of functional constipation.
Introduction: Passiflora incarnata, Valeriana wallichii and Withania somnifera are known to have psychotropic effects. These plants have been reported to alleviate stress, anxiety, and insomnia. This study aimed to evaluate the safety and efficacy of Zero Tension tablets in patients with mild to moderate stress, anxiety, and insomnia disorders. Methods: This study was a prospective, open-label, non-randomised study on patients (n = 100) with mild to moderate stress, anxiety, and insomnia disorders. All participants received two tablets with lukewarm water daily at night for 56 days. Primary outcomes were changes in the Hamilton anxiety scale (HAM-A), perceived stress scale (PSS), insomnia severity index, general health scores, serum levels of cortisol and dehydroepiandrosterone (DHEA) from day 0 to day 56. Secondary outcomes included adverse effects, changes in vital signs, haematological parameters, and serum biochemistry. Datasets were analysed at different assessment points using a t-test and one-way analysis of variance (ANOVA), as applicable. Results: Consumption of Zero Tension tablets significantly (p<0.001) reduced HAM-A, PSS, insomnia severity, and general health scores. Most participants experienced reduced stress, anxiety, and insomnia symptoms after 56 days of treatment. The serum cortisol and DHEA levels were also mildly reduced. No significant adverse effects or changes in vital signs, haematological, or blood biochemistry parameters were observed. Conclusion: The results suggested that the Zero Tension tablet is safe and could be an effective alternative to improve stress, anxiety and sleep disorders.
Background and aim: Symptoms of gynaecological disorders, including dysmenorrhea, leukorrhea, and premenopausal syndrome (PMS), are a common health concern, particularly among women of reproductive age. Due to the adverse effects of conventional treatments, the use of herbal remedies to treat various gynaecological disorders has increased. This study aimed to assess the efficacy and safety of Sachi Saheli formulations in subjects suffering from dysmenorrhea, leucorrhoea, and PMS. Methods: This was a single-arm, open-label, non-randomised prospective study. Female participants were recruited based on the inclusion and exclusion criteria. Study interventions were given to all participants for 90 days. Changes in blood haemoglobin levels were assessed from the baseline to the end of the study. Subjective symptoms and the investigators' severity assessment on 27 questionnaires were evaluated at baseline and the end of the study. Safety was also assessed by measuring liver and kidney function's haematological and biochemical markers. Results: A total of 120 female subjects were enrolled. After treatment with Sachi Saheli syrup and tablets, blood haemoglobin levels increased significantly compared to baseline (p < 0.0001). All subjects showed significant improvement in anxiety, menstrual pain, depression, and vaginal discharge symptoms. A significant improvement in the severity of physical and affective symptoms across 27 parameters was also observed. There were no significant changes observed in laboratory safety parameters. None of the subjects reported any adverse events during the treatment period. Conclusions: Sachi Saheli syrup and tablet may improve the symptoms of dysmenorrhea, leukorrhea and PMS.
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