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临床试验/CTRI/2024/08/072456
CTRI/2024/08/072456尚未招募3 期

Randomised comparative clinical study to evaluate the efficacy of Nagabala Ghrita and Gandha taila as Matra Basti and Brihmana Sneha orally in Asthi Kshaya with special reference to Calcium deficiency in children.

Dr Reshmi S Nair1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年8月20日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Significant improvement in the clinical features of Asthi Kshaya and Calcium deficiency

研究概览

简要总结

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.1    Due to increased growth and metabolism, the nutritional requirements of children are higher compared with adults.Among all the other micronutrients, emphasis is made on Calcium. Calcium plays a key role in Skeletal mineralisation and is required for normal growth, development and bone strength.Micronutrient deficiencies affect an estimated two billion people, or almost one-third of the world’s population.2Calcium, on the other hand, is at prevalence of deficiency, with 94% of the population at risk.3The prevalence of Calcium deficiency, in urban school-going children and adolescents alone, in India was found to be about 59.9%.4In addition to Calcium, magnesium, phosphorus and Vitamin D also play a vital role in Bone health; Wherein, Vitamin D plays a main role in increasing the intestinal efficacy of Calcium absorption.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, such as protecting against bone loss or preventing rickets but it is also important to monitor for its potential adverse effects and digestive issues such as constipation, bloating etc. Asthi Kshaya stands out, signifying a deficiency in the Asthi Dhatu. Wherein, Dalhana has defined Kshaya as ‘Swapramana Haani’.5Since Calcium and Phosphorus are major components of Asthi,Calcium deficiency can be considered as one of the major causes of Asthi KshayaAsthi Kshayaleads to Sthula dhatu Kshaya- Asthi KshayaSukshma roopa Majja KshayaUpadhatuand Mala Kshaya with respect toDanta Nakha, Keshaand Twacha.Since Ayurveda considers Asthi as a deeperDhatu, Asthi Kshaya Chikitsainvolves Basti karmaand employing substances with Snigdha, Guru GunaMadhura-Tikta rasa dravyaswhich include Ksheera, Ghrita etc. T*.In this regard, the current study is planned to do Dhatupratyaneeka Chikitsai.e., Asthi Dhatu Kshaya as per the guidelines of the Classical texts by the use of Snigdha, Madhura, Brihmana Dravya Bastiand Brihmana Snehaorally. Several Yogas are mentioned to be Brihmana, Balya, and Ojasya, but very few are clinically practised in the condition of Asthi Kshaya.In this context, Nagabala Ghrita, a classical formulation is a combination of drugssaid to be Balya, Brihmana, Ojasya, Vali-Palityaghna Varnya, Rasayanaetc.*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.The Asthi-sthairyakritandVata shamaka Karma along with Balya, Brihmana, Dipana-Pachana, Keshyaetc. Gunasof Gandha Taila dravyasmake it a suitable choice in Asthi Dhatu Kshaya.This study is an effort to evaluate the efficacy of Nagabala Ghritaand Gandha Tailaas Matra Basti and Brihmana Snehaorally in Asthi Kshayawith 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

  • Subjects in the age group 3 years -6 years.
  • Subjects irrespective of their gender, religion and socio-economic status.
  • Subjects diagnosed with classical symptoms of Asthi kshaya.
  • Subjects with classical symptoms of Calcium deficiency.
  • Subjects whose parents are willing to sign the written consent form and follow the treatment protocol will be included.
  • Subjects with mild to moderate calcium deficiency.

排除标准

  • Severe cases of Hypocalcemia with Tetany, Seizures, Paresthesia, Laryngospasm, Bronchospasm and Arrhythmia.
  • Subjects with any Congenital Anomalies.
  • Subjects with Endocrinal disorder related to growth.
  • Subjects with Metabolic disorders.
  • Subjects with Malabsorption Syndromes.

结局指标

主要结局

Significant improvement in the clinical features of Asthi Kshaya and Calcium deficiency

时间窗: Within one year of the study.

次要结局

  • Generation of in-depth analysed data on the different aspects of the disease.(Generation of data on possible unexpected drug reactions.)

研究者

发起方
Dr Reshmi S Nair
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Reshmi S Nair

Sri Sri College of Ayurvedic Science and Research,Bangalore

研究点 (1)

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