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临床试验/CTRI/2024/12/077600
CTRI/2024/12/077600尚未招募2 期

An Exploratory Study to Evalauate the Combined Efficasy of Sinduthaadi Modaka and Nasya of Katutumbi Taila in the Management of Dhatvagnimandya Vikrati (Hypothyroidism)

post graduate institute of ayurved jodhpur1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年12月13日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
To Assessment Of Subjective And Objective Parameters Before And After Treatment

研究概览

简要总结

INTRODUCTION

Hypothyroidism is the most common endocrinal disorder that occurs when the thyroid gland does not make enough thyroid hormone to meet the body’s needs. Thyroid gland produces two hormones Thyroxine (T4) & Triiodothyronine (T3). These hormones play a critical role in cell differentiation during development and help maintain thermogenic and metabolic mechanism. Thyroid hormone regulates the metabolism and affects nearly every organ in the body. Without enough thyroid hormone, many of the body’s functions slow down. It is based on belief, that health and wellness depend on a delicate balance between the mind, body and spirit. In the changing lifestyle of 21stcentury hypothyroidism is considered as one of the commonest diseases. Hypothyroidism is the major endocrine disorder seen in general population. It is characterized by the deficiency of thyroid hormones to abnormal levels. This condition leads to the reduction in Basal metabolic rate, affects physical and mental growth during infancy or childhood. The dysfunctioning of the ’Agni’ is the basic cause of the clinical manifestations of Hypothyroidism. The hypofunctioning of jatharagni’ in turn affects "Dhatwagni" which acts as the basic factor for the occurrence of the diseased condition In Ashtanga Hridaya, Vagbhata emphasizes the importance of Kayagni and its direct implication on the status and maintenance of the Dhatwagni, the Vriddhi/Kshina Avastha of the Jatharagni would result in the same status of Dhatvagni too. Kayagni present in its own place, has portions of itself, pre- sent in the Dhatus also. Their decrease (in quantity, qualities or functions) and in- crease (in quantity, qualities or functions) give rise to increase and decrease of the Dhatus (respectively). If preceeding Dhatu is increased or decreased, it will increase or decrease the succeeding Dhatu too. Ayurveda is named as the science of life. It is one of the world’s oldest holistic healing system. In Ayurvedic classics hypothyroidic problems are not described under a particular disease. On the basis of Ayurvedic principles, we can understand the pathology of Hypothyroidism as that “Roga Sarveapi Mandagno”. In modern terminology “Agnimandya” can be understood as decreased caloric expenditure which is present at systemic and cellular level. It is basically caused due to dysfunctioning of the Agni. It is a metabolic disorder in which Agni (Jatharagani, Bhutagni, Dhatwagni) are at very low level. Vriddhi of Vata Dosha and Kapha Dosha and Kshaya of Pitta is most important in genesis of disease Hypothyrodism.Many of Rasa Pradoshaja Vikaras which have been mentioned in Charak Samhitaare similar to the clinical features of Hypothyroidism i.e. Ashraddha, Aruchi, Gaurava, Tandra, Angamarda, Panduroga, Klaibya, Srotorodha, Agnimandya etc.

METHOD OF PREPARATION OF TRIAL DRUG Drug A: Sinduthaadi modaka – All the ingredients are taken in equal quantity and a fine powder is prepared and jaggery is added equal to all 4parts drugs taken and modaka is prepared. Drug

B: Katutumbi taila – All the ingredients are taken in equal amount and a fine paste is prepared. Before preparation of medicated taila the crude Taila should have processed with a special procedure. Tailais heated till it becomes free from froth. 4 part of water is added along with 1 part of paste. It is boiled on moderate heat till oil becomes free from water then oil is filtered. When all the darva dravayas have evaporated the moisture in kalka will also begin to evaporate at this stage. It has to be stirred more oftenand carefully to ensure paste does not stick.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients willing for the trial.
  • Patients between the age of 18-60 years of either sex.
  • Patients who are newly diagnosed of Hypothyroidism with increased TSH levels.
  • Subjects coming with chief complain of unexplained weight gain cold intolerance constipation hoarseness of voice fatigue depression edema.
  • Subjects detected with TSH between 5-20 Miu/L.

排除标准

  • Patients below the age of 18 years and above 60 years.
  • Patients suffering from congenital hypothyroidism and secondary hypothyroidism hypertension.
  • Subject having multi neoplasm toxic goiter is excluded.
  • Patients who have undergone any type of thyroid surgery.
  • Pregnant and lactating women are excluded.

结局指标

主要结局

To Assessment Of Subjective And Objective Parameters Before And After Treatment

时间窗: 90 DAYS

次要结局

  • To observe any side effects if occur during(clinical trial)

研究者

发起方
post graduate institute of ayurved jodhpur
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

DR GUDDI

post graduate institute of ayurved, jodhpur

研究点 (1)

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