A Randomised controlled trial to evaluate the efficacy of Lakshadi Guggulu and Haridra (Lakadong Turmeric) in improving Vitamin D deficiency in asthikshaya condition of NE region” (Preprint)

BACKGROUND The recent data show that in India, 61 million people have osteoporosis, of whom 80 per cent are women. The peak incidence of osteoporosis in India occurs 10-20 years earlier than in Western countries, which indicates our poor health economics. Osteoporosis is a major public health concern characterised by low bone mass and abnormal bone structure, leading to increased bone fragility and fractures. The factors responsible for osteoporosis are gender, advancing age after menopause, low BMI, family history, alcohol consumption, vitamin deficiency, smoking, sedentary lifestyle and poor diet. Vitamin D insufficiency can result from nutritional deficiency and/or inadequate sun exposure in elderly patients confined to their homes and in patients with chronic diseases. According to Ayurvedic principles, osteoporosis can be related to the concept of Asthikshaya. In line with the principle of Ashraya-ashrayee Bhava, Asthi and Vata are inversely proportional concerning Vriddhi and Kshaya. Vata Vriddhi results in the Kshaya of Asthi Dhatu. The symptoms of Asthikshaya resemble osteoporosis, a major health concern among the ageing population. OBJECTIVE The above study is planned to evaluate the efficacy of Lakshadi Guggulu in asthikshya patients and compare it with the combined therapy of Haridra and Lakshadi Guggulu on asthikshaya. METHODS It will be a randomised controlled trial The Sample size will be of 60 subjects (30 patients in each group) suffering from Asthiskhay and fulfilling the inclusion criteria RESULTS After treatment, the patients will be monitored for progress and recorded in a specially prepared case sheet. The observations will be analysed based on assessment parameters (both subjective and objective) in a critical and scientific manner, and the results will be statistically evaluated for significance with the consultation of a biostatistician. CONCLUSIONS The study will be concluded after analysing the data. CLINICALTRIAL The trial has been registered with the CTRI in India.The registration number for this trial is CTRI/2024/10/075550.