A Randomized Controlled Clinical Study to Evaluate the Effect of Nagabala Ghrita as Matra Basti and Oral Route in Children with Asthi Kshaya (Calcium Deficiency), Compared with Oral Calcium Supplementation
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 105
- 试验地点
- 1
研究概览
简要总结
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The period of childhood is recognized as a phase of significant growth, wherein optimal growth is attained through a well-balanced diet and the absence of disease. Due to increased growth and metabolism, the nutritional requirements of children are higher compared with adults.
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Achieving optimal growth requires a proper diet that ensures sufficient intake of both macronutrients and micronutrients. While macronutrients have received more attention, micronutrients should not be overlooked.
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Micronutrient deficiencies affect an estimated two billion people, or almost one-third of the world’s population. Calcium, on the other hand, is at prevalence of deficiency, with 94% of the population at risk.
And in about 59.9% of urban school-going children and adolescents alone.
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Children with strictly vegetarian diet and those who have low intake of diary supplements are especially at risk of calcium deficiency. In older children who are mostly attracted to Western diets which lacks dietary calcium, calcium supplements are required to meet bone mineral accretion requirements.
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It was reported that intakes of about 900 mg/d led to calcium retention of about 172 mg/d [18] and that intakes of about 700 mg/d let to retentions of about 120 mg/day. There is a substantial variability in the amount of skeletal calcium accreted in this age range of 4 to 8 years.
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Presently, calcium supplements are prescribed prophylactically in children to support healthy bone development and overall growth. There is a wide range of calcium supplements available in the market, each claiming various benefits but it is also important to monitor for its adverse effects on the digestive system like constipation, fatigue, dizziness, renal calculi etc.
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Since Calcium and Phosphorus are major components of Asthi dhatu, Calcium deficiency can be considered as one of the major causes of Asthi dhatu Kshaya.
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Dhatupratyaneeka Chikitsa with respect to Asthi Dhatu Kshaya includes Bastikarma, the use of Snigdha,guru, Madhura- tikta, Brihmana Dravyas including Ksheera, Ghrita etc.
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In this context, Nagabala Ghrita, a classical formulation is a combination of drugs said to be Balya, Brihmana, Ojasya, Vali-Palityaghna, Varnya, Rasayana etc.6 The biological activities of the genus Grewia (Nagabala)are said to have high contents of Calcium and are extremely important for curing severe pain in bones and also help to increase the mobility of joints.
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Calcimax plus suspension containing Calcium, Vitamin D, Zinc and Magnesium in the absorbable form and is a standard preparation used as a bone and joint health supplement in children. This study is an effort to compare the efficacy of Nagabala Ghrita as Matra Basti followed by Brihmana Sneha orally and Calcimax suspension in Asthi Kshaya with special reference to Calcium deficiency in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 3.00 Year(s) 至 6.00 Year(s)(—)
- 性别
- All
入选标准
- •Participants in the age group of 3 years- 6 years.
- •Participants of any gender, religion or socio-economic background.
- •Participants diagnosed with Asthi kshaya based on classical Ayurvedic symptoms and supported by relevant clinical and laboratory findings.
- •Participants with mild to moderate calcium deficiency confirmed by laboratory findings.
- •Participants whose parents or legal guardians provide written informed consent and agree to comply the treatment protocol.
排除标准
- •Participants below 3 years or above 6 years of age.
- •Participants with severe calcium deficiency requiring emergency medical intervention.
- •Participants with chronic systemic illnesses such as congenital bone disorders, renal disease, malabsorption syndrome, or metabolic disorders.
- •participants with a known history of hypersensitivity to any ingredients in the study formulations.
- •Participants currently undergoing any treatment that may interfere with calcium metabolism or bone health.
- •Participants who are unwilling or whose parents/guardians do not provide written informed consent.
研究者
Dr Sudheer B R
Sri Sri College of Ayurvedic science and research Cuttack
