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Introduction Anal fissures are tears in the anal canal that cause pain, bleeding, and spasms. They can be treated with non-operative options such as sitz baths, local anesthetics, topical nitrates, oral fiber, and calcium channel blockers, but some patients require surgery. Topical nitrates have side effects such as severe headaches, while topical calcium channel blockers can cause itching. There is a need to explore alternative treatments with fewer side effects. This proof-of-concept pilot study aimed to compare the efficacy and safety of a combination of Arsha Hita™ tablets and ointment (Shree Dhootapapeshwar Limited, Mumbai Maharastra, India) (test treatment) with a combination of lidocaine 1.5% w/w + nifedipine 0.3% w/w cream for local application and Isabgol powder (6 g) orally as an active comparator (standard treatment), which is the standard treatment of anal fissures as per the Association of Colon and Rectal Surgeons of India (ACRSI) guidelines. Methodology This study was a single-center, prospective, randomized-controlled study conducted in Karnataka, India. Participants were screened for anal fissures and randomized to receive either standard treatment (Group A) or test treatment (Group B) for 14 days, and were re-evaluated after two, four, and six weeks. The study assessed signs and symptoms related to anal fissures, such as pain post-defecation on Visual Analog Scale (VAS), bleeding per anus grading, wound healing grade, stool consistency, and stool frequency. Compliance, inter-current illness, and concomitant therapy were noted at each visit. The study used independent sample t-tests to compare variables at baseline and chi-square or Fisher's exact tests to compare the number/proportion of participants achieving primary and secondary endpoints. Mann-Whitney U test was used to compare median composite scores at baseline and Visit 4, and Friedman's two-way analysis of variance was used to compare median composite scores across the four visits (p < 0.05 was considered significant). Descriptive analysis was used to assess VAS, bleeding, and healing grades. Results The study included 53 participants with anal fissures, of which 25 out of 27 allocated in Group A (two drop-outs) received standard treatment, and all 26 allocated in Group B received Arsha Hita treatment. At the end of the study, 11 participants in Group B achieved a 90% reduction in composite scores compared to only three patients in Group A (p<0.05). Both groups showed improvement in pain on defecation, severity of bleeding, healing of anal fissure wound, and participant's and physician's global impression score. Group B had significantly better results in terms of VAS score, resolution of per-anal bleeding, and physician's global impression score (p<0.05). There were no adverse events in either group during the six-week treatment period. Conclusion The pilot study provides evidence that the combination of Arsha Hita tablets and Arsha Hita ointment may be more effective and safer for treating anal fissures than the standard treatment. The test treatment group experienced greater pain relief, complete resolution of per-anal bleeding, and better global impression scores than the standard treatment group. These findings suggest the need for further research through larger, randomized controlled trials to determine the efficacy and safety of Arsha Hita in treating anal fissures.
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Abstract Rectal Prolapse is a condition where the rectum protrudes beyond the anus. The explanation of this condition can be traced back to ancient Ayurveda text like Susruta Samhita, Ebers Pappyrus of 1500 B.C., etc. The exact cause of rectal prolapse is unclear but it is predominant on female gender and on people having constipation, previous anorectal surgeries etc. Both partial and complete varieties of rectal prolapse are extremely debilitating because of the discomfort of the prolapsing mass and variety of symptoms like rectal bleed, intermittent constipation or fecal incontinence. Although, diverse modalities of surgical management of rectal prolapse are present, no single optimal procedure is proved and the choice of operation is determined by the patient's age, sex, degree of incontinence, operative risk, as well as by the surgeon's experience. In Ayurveda, Guda Bhramsa (Rectal prolapse) is explained by Acharya Susruta under Kshudra Rogas (chapter of minor diseases) and has elaborated it's conservative management very beautifully. In this case, a female with partial rectal prolapse was treated with Kshara application and managed without complications. So, Kshara application can be a safe and effective alternative for the management of rectal prolapse.
Resumo O prolapso retal é uma condição em que o reto se projeta para além do ânus. A explicação desta condição foi relatada em antigos textos Ayurveda como Susruta Samhita e Ebers Pappyrus, datados de 1500 aC. A causa exata do prolapso retal não é clara, mas essa condição é predominante no sexo feminino e nas pessoas com constipação e histórico de cirurgias anorretais anteriores. Tanto o prolapso retal parcial quanto total são extremamente debilitantes devido ao desconforto da massa prolapsante e da variedade de sintomas como sangramento retal, constipação intermitente ou incontinência fecal. Embora diversas modalidades de tratamento cirúrgico para corrigir o prolapso retal tenham sido relatadas na literatura, nenhum procedimento é consensual; a escolha da operação é determinada pela idade, sexo, grau de incontinência, risco operatório e experiência do cirurgião. Na Ayurveda, Guda Bhramsa (prolapso retal) é explicado por Acharya Susruta no Kshudra Rogas (capítulo de doenças menores) e seu manejo conservador é descrito de forma bastante completa. No presente caso, uma paciente do sexo feminino com prolapso retal parcial foi tratada com aplicação de Kshara e administrada sem complicações. Assim, a aplicação de Kshara pode ser uma alternativa segura e eficaz para o manejo do prolapso retal.
