Evaluation Of Comparative Efficacy Of Panchagavya Ghrita [ Oleation Therapy Versus Medicated Enema] With Amalakyadi Decoction Against Standard Control In Managing Side Effects of Chemo-Regiotherapy in Cancer Patients (Preprint)

Abstract

It was discovered that the anticipated number of cancer occurrence cases in India for the year 2022 was fourteen lakh, sixty-one thousand, four hundred and twenty-seven. Cancer is predicted to strike one in nine Indians at some point. The most common cancerous locations in men and women, respectively, are the lung and breast. [1]. Stem cell therapies, hormone therapy, anti-angiogenic drugs, immunotherapy, and dendritic cell-based immunotherapy are examples of contemporary therapeutic approaches; The most often used conventional treatment modalities include radiation, chemotherapy, and surgery. [2]. However, all these therapies have certain limitations, such as radio and chemotherapy, which may still affect healthy cells in the body. Moreover, these modalities induce liver or kidney damage [3]. The most typical adverse effects of chemotherapy are nausea, vomiting, exhaustion, altered taste, decreased appetite, hair loss, dry mouth, constipation, weight loss or increase, and recurrent headaches. [4]. These adverse effects lower patients' quality of life and cost them and their families academic, professional, and financial losses due to recurrent hospitalization and disturbed family-social lives [5]. Hospitalization is sometimes required due to certain concerns. Find a holistic remedy for these side effects to fix these concerns. Given this, we must find a safe and effective Ayurvedic remedy for these symptoms. Panchgavya Ghrita, a classical formulation of five Desi cow products, is rich in antioxidants and immune modulators that help manage these symptoms and is beneficial in cancer management due to its proven anti-cancer potential. [6].

1. To assess the efficacy of Panchgavya Ghrita Snehapana[Oleation Therapy ] with Amalakyadi Kashaya [decoction] in managing side effects of Chemotherapy and Radiotherapy based on improvement in the patient's quality of life. 2. To assess the efficacy of Panchgavya Ghrita Matra Vasti [Medicated Enema] with Amalakyadi Kashaya[decoction] in controlling chemotherapy and radiation side effects according to a rise in quality of life 3. To evaluate and contrast the effectiveness of Panchgavya Ghrita Snehapana [Oleation Therapy ], Matra Vasti[Medicated Enema], and Amalakyadi Kashaya versus Standard care in modern science in managing side effects of Chemotherapy and Radiotherapy on improvement in Q.O.L.

: It is a randomized Single (Assessor) Blind Three Arm Standard Control Superiority Comparative Interventional study in which a total of 36 cancer patients on chemo or radiotherapy will be divided into three groups (12 patients in each group) for this study i.e. Group A (N=12) will be intervened with oral intake of Panchagavya Ghrita (10-15gm BD) and 20-30 ml Decoction of Amlaki (Phyllanthus emblica Linn.)+Yashtimadhu (Glycyrrhiza glabra) + Shatpushpa(Foeniculum vulgare) twice daily for 8 days. Group B (N=12) will receive Matra Vasti (medicated enema) with Panchagavya Ghrita (60 ml once daily) and oral intake of 20-30 ml Amalakyadi Kashaya i.e. decoction of Amalaki (Phyllanthus emblica Linn.)+ (Glycyrrhiza glabra) + (Foeniculum vulgare) twice daily for 8 days. Group C (N=12) will undergo Standard symptomatic treatment in Modern science for the management of side effects of chemotherapy and radiotherapy as suggested by an oncologist. Follow-ups of the patients will be made on the 8th, 16th, and 30th day of the stipulated group-wise intervention.

Using the EORTC QLQ-C30 (version 3) as a tool, the study's main goal is to determine the optimal way to administer Panchgvya Ghrita with oral Amalkyadi Kashaya to enhance the standard of living for cancer patients undergoing radiation, chemotherapy, or both. The secondary outcome of this study is to assess and compare the efficacy of Panchgvya Ghrita (by rectal and oral route) with oral Amalkyadi Kashaya against standard care in decreasing the severity of symptoms generated as side effects of Chemo- radiotherapy in cancer patients who will be assessed based on certain parameters e.g. Bristol stool scale, Nausea Likert, DVA scale, CIPN, VAS scale, and fatigue severity scale.

This study will evaluate of comparative efficacy of Panchagavya Ghrita (Snehapana versus Matravasti) with Amalakyadi Kashaya against Standard Control in managing side-effects of Chemo-Radiotherapy.  If the Ayurvedic treatment protocol, combining Panchagvya and Panchakarma improves the quality of life for cancer patients undergoing radio and chemotherapy, it can improve therapeutic outcomes and patient compliance.  Clinical evidence suggests a simple, safe, cost-efficient, and successful strategy for managing  This study provides clinical information that could inform future multi-centric pragmatic trials to enhance the prognosis of advanced cancer patients with the same strategy. Students can study the positive therapeutic outcomes and synergistic effects of a scientific, integrative, and multidisciplinary approach with Panchakarma and Panchagvya in Ayurveda and conventional medicine based on gold standard parameters in cancer to expand their scientific approach to Ayurvedic Oncology.