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临床试验/CTRI/2025/10/096723
CTRI/2025/10/096723尚未招募2/3 期

A Cross-Sectional study on Rasavaha Srotodushti Lakshana in primary Hypothyroidism and evaluating the therapeutic efficacy of Kanchanar Guggulu with Rasapachak Kwatha versus Kanchanara Triphala Kwatha on Thyroid function.

All India Institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
56
试验地点
1
主要终点
Reduction in TSH (mIU/L)

研究概览

简要总结

Hypothyroidism is the most common endocrine disorder that affects a significant portion of the global population. The prevalence of hypothyroidism in urban India is 10.95% with a greater incidence in females and elderly persons. The thyroid gland produces two hormones, Thyroxine (T4) and Triiodothyronine (T3). The deficiency of thyroid hormone is a common condition worldwide. It affects almost all body systems and has a wide variety of clinical presentations from being asymptomatic to, in rare cases, life threatening. Ayurveda does not currently have a description of any disease condition comparable to hypothyroidism. Yet, several references are scattered in various texts. Understanding of hypothyroidism as per Ayurvedic science suggests Kapha and Meda derangements, With the involvement of Kapha, Vata dosha, along with the Srotas involved are Rasavaha, Mamsavaha, Medovaha, Purishavaha, Annavaha, Pranavaha, Manovaha, and Arthavavaha.

NEED OF THE STUDY: On the basis of clinical manifestation and etiological factors of hypothyroidism it may be considered primarily caused due to Derangement of Agni, Rasavaha Srotas and Medovaha Srotas as per ayurveda perspective.

Some previous studies have documented the role of Rasavaha Sroto dushti in hypothyroidism, however, to the best knowledge of the authors, none of the previous studies have used validated performa (Questionnaire) for the same, which reduces their scientific credibility. This study may provide a deeper understanding of the disease’s pathophysiology from an Ayurvedic perspective. It also helps in identifying which symptoms are most prevalent or severe in this specific population, guiding the development of more targeted interventions.

This study also plans for further confirmation of association between Rasavaha srotodushti lakshanas and hypothyroidism through the usage of Rasapachak Kwatha, which acts mainly on Rasa Dhatu. If the Rasapachak Kwatha can mitigate the symptoms of hypothyroidism it may uphold the association of Rasavaha Srotodushti lakshanas in hypothyroidism. Additionally, it may also demonstrate how Ayurvedic treatments can more effectively balance the disturbances in Rasavaha Srotas and provide a holistic approach to managing hypothyroidism. AIM:

Examine the relationship between Rasavaha Srotodushti symptoms and hypothyroidism by comparing the therapeutic effects of Rasapachak Kwatha combined with Kanchanar Guggulu versus Kanchnara Triphala Kwatha combined with Kanchanar Guggulu, based on various subjective and objective parameters.

OBJECTIVE:

Primary Objective:

1)    To assess the therapeutic effects of Rasapachak Kwatha combined with Kanchanar Guggulu versus Kanchnara Triphala Kwatha combined with Kanchnar Guggulu on hypothyroidism, based on thyroid function (TSH).

Secondary Objective:

1)    To compare their impact on T3, T4, and clinical symptoms of hypothyroidism

研究设计

研究类型
Interventional
分配方式
Randomized
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

  • Confirmed primary hypothyroidism TSH Greater than 4.5mIU/L to less than19mIU/L, low/normal T
  • Uncontrolled hypothyroidism’s Patients.
  • Willing to provide written Informed consent.
  • Patients having Symptoms of Rasadushti in any grade Patient having symptoms of Rasadushti last for one month No acute illnesses.

排除标准

  • Secondary/tertiary hypothyroidism.
  • Patient with congenital hypothyroidism, goitorous hypothyroidism, transient hypothyroidism.
  • Pregnancy or lactation.
  • Comorbidities like CRF, known case of Hepatitis B, Jaundice, Tuberculosis, HIV, CAD, severe anaemia.
  • Patient whose symptoms are worsely aggravated after leaving the modern drug levothyroxine (for washout period of 8 days) Mentally ill/retarded patients.
  • Patients with drug induced hypothyroidism, Recent thyroid surgery or radioiodine therapy within 1-year of the study.
  • Uncontrolled Diabetes Mellitus, hypertension.
  • Patient undergoing treatment for any other systemic illness.

结局指标

主要结局

Reduction in TSH (mIU/L)

时间窗: 0 and 45th days.

次要结局

  • Changes in T3,T4,clinical features of hypothyroidism-Rasavaha srotodushti lakshana score(0 and 45th day.)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Salve Arti Madhukar

All India Institute of Ayurveda

研究点 (1)

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