Evaluation of the efficacy of Gandamalakandan rasa and Kanchanar Guggulu along with tumbi taila nasya in the management of Hypothyroidism-A randomised comparative clinical study.

Phase 2/3

Not yet recruiting

• Conditions: Other iodine-deficiency related thyroid disorders and allied conditions. Ayurveda Condition: MEDOVAHASROTOVIKARAH,

• Registration Number: CTRI/2023/02/050086
• Lead Sponsor: All India Institute of Ayurveda

Brief Summary

Need of the Study

Prevalence of hypothyroidism in India is 10%.The prevalence ratio of male:female is 1:6. Thyroid hormone is required for the normal functioning of each and every tissue of the body. Hence, its deficiency manifests as multisystem involvement. The only treatment available in modern medicine is in the form of synthetic hormone Levothyroxine. Even after years of treatment,it is associated with the failure to provide relief in clinical manifestations.Moreover ,excessive thyroid replacement carries the 2 7 potential for serious long term metabolic complications (e.g., accelerated osteoporosis). Thyroid hormone increases bone mineral resorption.The net effect of excessive thyroid hormone is increased bone resorption and a subsequent decrease in bone density i.e.osteoporosis. Looking to the pathogenesis and complications of hypothyroidism, it requires a systemic and radicle therapy for which Ayurveda may provide a ray of hope through its holistic approach.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-03
• Last Update Posted: 2023-02-14

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1.TSH levels from 5.6mIU/L to 19.9mIU/L 2.Patients having signs and symptoms of Hypothyroidism 1)weight gain 2)cold intolerance 3)fatigue 4)dry skin 5)dry hair 6)menorrhagia 7)constipation 8)hoarseness of voice 9)alopecia 10)aches and pains 11)muscle stiffness 12)deafness 13)depression 14)infertility 15)psychosis 16)periorbital edema 17)anaemia 18)bradycardia 19)hypertension 3.Nasya Arha (Patients suitable for Nasya).

Exclusion Criteria

1.Patients having TSH level greater than 19.9mIU/L 2.Recent thyroid surgery (within 12 months) 3.Patients suffering from diseases like 1)HIV 2)TB 3)Encephalopathy 4)Goiter 5)Other endocrine disorders and other autoimmune disorders 6)Lactating and pregnant women 7)Uncontrolled Diabetes Mellitus 8)uncontrolled Hypertension.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PRIMARY OUTCOME	(DAY-0) (DAY-29) (DAY-57)
Improvement in the signs and symptoms of hypothyroidism.	(DAY-0) (DAY-29) (DAY-57)
(after 4 weeks and 8 weeks)	(DAY-0) (DAY-29) (DAY-57)

Secondary Outcome Measures

Name	Time	Method
Improvement in quality of life in Hypothyroidism patients.

Trial Locations

Locations (1)

All India Institute of Ayurveda; 🇮🇳 Delhi, DELHI, India

All India Institute of Ayurveda

🇮🇳Delhi, DELHI, India

Dr Kanchan Gajare

Principal investigator

8595716491

kanchangajare1996@gmail.com