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Clinical Trials/CTRI/2024/05/066731
CTRI/2024/05/066731Not yet recruitingPhase 3

A Comparative Clinical Study To Evaluate The Effect Of Kulattha Yusha As Pathya Selected Yoga Techniques Over Vidanga Choorna As Shamanoushadhi In The Management Of Hypothyroidism.

Dr Aishwarya1 site in 1 country60 target enrollmentStarted: May 15, 2024Last updated:

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Efficacy of Kulattha yusha vidanga choorna yoga in reducing the TSH value by comparing the zulewski clinical score for hypothyroidism

Study Overview

Brief Summary

Thyroid disease is one of the most prevalent endocrine disorders worldwide Hypothyroidism is a hypo-metabolic clinical state resulting from inadequate production of thyroid hormone This condition is associated with symptoms like poor appetite weakness or tiredness feeling of cold poor memory constipation and weight gain Prevalence of hypothyroidism in India is around 11% and Females suffer more than male with ratio 6:1 prevalence of clinical Hypothyroidism is about 4%.

Thyroid hormone regulates all metabolic activities in the body it can be compared to Dhatvagni. While analysing the signs and symptoms of Hypothyroidism in Ayurvedic view Agnimandya due to Kapha Vata Vriddhi and Pittakshaya is seen This is due to unhealthy food habits non-nutritious food sedentary life styles & stress

In this present study hypothyroidism is selected by observing its incidence and it is an attempt to cure the disease from its root cause As the incidence of hypothyroidism is due to improper dietary habits and iodine deficiency changes in diet and lifestyle plays a major role in control of thyroid hormone level In Ayurveda much importance is given to Pathyahara sevana (Diet) and Yoga Proper pathyahara sevana holds an important role in diseased condition than medicine by regulating the metabolism function (Agni) of body and balancing the tridosha

Kulatta yusha is having Kaphavatahara, Medhoghna Agni Dipaka properties Vidanga is Agni Dipana and Pachana Vata Anulomana Yogasana and Pranayama helps in total physical and mental wellbeing Improves metabolic process and helps to reduce body weight and stress  Pranayama is a breathing process that is directly connected with brain and central nervous system it also has a strong connection with the functioning of hypothalamus Thus this study is designed to evaluate the effect of Kulattha yusha as a Pathya selected yoga techniques along with Vidanga churna as a shamanaoushadi individually and also to compare their efficacy with one another in Hypothyroidism

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
None

Eligibility Criteria

Ages
20.00 Year(s) to 50.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Subject belonging to Age group 20 to 50 years irrespective of gender are included Subject with the TSH value more than 5.5mIU/L to less than 25mIU/L not be associated with the routed value of T3 and T4.

Exclusion Criteria

  • Subject with congenital hypothyroidism chronic history of hypothyroidism less more than 5yrs and secondary hypothyroidism Subject having any of the diagnosed systemic illness which interrupt the present intervention Subject with toxic goiter pregnant and lactating women are excluded Subject who has undergoes any thyroid surgery.

Outcomes

Primary Outcomes

Efficacy of Kulattha yusha vidanga choorna yoga in reducing the TSH value by comparing the zulewski clinical score for hypothyroidism

Time Frame: 61th day

Secondary Outcomes

  • Efficacy of Kulattha yusha Vidanga choorna Yoga in relieving other associated symptoms of Hypothyroidism like weight gain Stiffness of joints Hair loss Diminished sweating Dry skin Constipation(61th day)

Investigators

Sponsor
Dr Aishwarya
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Aishwarya

Government Ayurvedic Medical College and Hospital , Mysuru

Study Sites (1)

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