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.
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Reduction in TSH (mIU/L)
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Reduction in TSH (mIU/L)
Time Frame: 0 and 45th days.
Secondary Outcomes
- Changes in T3,T4,clinical features of hypothyroidism-Rasavaha srotodushti lakshana score(0 and 45th day.)
Investigators
Dr Salve Arti Madhukar
All India Institute of Ayurveda