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临床试验/CTRI/2024/08/071783
CTRI/2024/08/071783尚未招募2/3 期

Effect Of Makandi (Coleus Forskohli Briq.) Moola Churna Capsule In The Management Of Subclinical Hypothyroidism–An Open Labeled Clinical Trial

Dr. Siddhayya swami1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年12月1日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Thyroid profile

研究概览

简要总结

Thyroid gland diseases are the most abundant endocrine disorder after Type 2 Diabetes Mellitus in terms of prevalence. Hypothyroidism affects 6.4% of the 42 million thyroid disorder patients in India and 200 million worldwide, making it the most common. There is no universal consensus on the management of subclinical hypothyroidism. Some practitioners prescribe low-dose levothyroxine, which can cause adverse symptoms such as anxiety, increased appetite, irritability, and mood swings.

Sub Clinical Hypothyroidism typically develops slowly and initial symptoms are often nonspecific and diffuse. It’s not uncommon for the diagnosis to be overlooked. However, the physical changes that come with the illness are characteristic: dry, rough skin; pale and puffy complexion; hair loss; change in voice; decreased appetite; and menstrual abnormalities, etc.

Makandi (Coleus forskohli Briq*)* has the Rasa qualities of Tikta, Katu and Madhur, along with Tikshna and Vikasi guna. Its virya is Ushna, and Vipak is Madhur.

The active ingredients in Coleus Forskolin include Diterpene, Forskolin (coleonols) and Volatile oils.

In a one study it is stated that, chronic treatment of cultured thyroid cells with forskolin sensitizes adenylate cyclase response to acute stimulation by forskolin or thyrotropin (TSH). This positive regulation, similar to that produced by TSH, occurs between 2 and 3 days of culture.

“Give a Drug as a Whole”, As a fundamental element of Pada Chatushtaya, drugs play a crucial role in treatment efficacy, contingent upon appropriate dosage and formulation. Modern scientific progress has popularized the use of extracts and isolated compounds. Ayurveda’s Rasa Panchaka principles attribute drug actions to components like Rasa-Guna-Veerya-Vipaka-Prabhava, emphasizing holistic effects Chemical isolation may lead to adverse effects, as drugs contain synergistic fractions that mitigate harm. Ayurveda advocates whole-drug usage to achieve desired effects without side effects, aligning with its holistic approach to health. Therefore, treating the individual as a whole and administering drugs in their entirety reflect Ayurveda’s core principles. Ayurveda always advocates “Shamanam Nah Tu Kopanam”. Let us try to understand the real essence of the Ayurveda with help of its own basic concepts.

Thus, this clinical trial aims to assess the efficacy of the entire moola of Makandi in managing Sub Clinical Hypothyroidism, aligning with Ayurvedic principles. We can get some references of Hypothyroidism as Kaklaka granthi apachaya, Galaganda, Gandamala , Apachi & to some extent Agnidushti being the nidan behind it.

Building Confidence on Single drug therapy & Low cost with High effective therapy is need of the hour. Keeping this in view Single Drug with effective dosage W.S.R to the drug MAKANDI (Coleus forskohli Briq*) moola churna* Capsule is considered for current study.

研究设计

研究类型
Interventional
分配方式
Na
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

  • 1 Patient not on any Anti-thyroid medication 2 Where TSH value is above normal value 4.5mIU/L but below 10mIU/L 3 Individuals of either sex between the age group of 18 to 60 years fulfilling diagnostic criteria of subclinical hypothyroidism.

排除标准

  • 1 Patient on Anti-thyroid medication.
  • 2 Serum TSH value more than 10mIU/L.
  • 3 Subjects with congenital hypothyroidism & Subjects who have undergone thyroid surgery.
  • 4 Patients with complications of hypothyroidism like cardio vascular disorders, infertility, Myxedema coma etc.
  • 5 Patients with alcohol dependency or drug dependency.
  • 6 Pregnant or lactating women.
  • 7 Patients suffering from major systemic illness and long term drug treatment Rheumatoid arthritis etc.

结局指标

主要结局

Thyroid profile

时间窗: 0th day and 42th day

次要结局

  • Weight Loss and Inch loss in Waist circumference,Mid-Thigh and Mid-arm circumference(0th,15th ,30th,42nd day)

研究者

发起方
Dr. Siddhayya swami
申办方类型
Other [Self Sponsered PG disertation work]
责任方
Principal Investigator
主要研究者

Dr Siddhayya Swami

KAHERs Shri B M K Ayurveda Mahavidyala Shahapur Belagavi Karnataka-590003

研究点 (1)

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