Clinical study to evaluate the effect of Shakotaka Taila nasal drops with Krimighnadi Kashaya and Phalatrikadi Kashaya orally in the management of Primary Hypothyroidism with Obesity

A Comparative Clinical Study to evaluate the effect of Shakotaka Taila Pratimarsha Nasya with Krimighnadi Kashaya and Phalatrikadi Kashaya in the management of Primary Hypothyroidism with Obesity

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/069901

Enrollment

140

Registered

2024-07-04

Start date

Unknown

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E039- Hypothyroidism, unspecified Health Condition 2: E038- Other specified hypothyroidism

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Subjects fulfilling the diagnostic criteria. Both fresh and treated cases of hypothyroidism will be included. Freshly detected and untreated cases of hypothyroidism. Established and treated cases of hypothyroidism also who are ready to discontinue the earlier medication with Flush out period of 15 days. Patients with hypothyroidism BMI more than 25. Subjects with serum TSH more than 5 to less than 10 ml IU/L and more than 10ml Primary Hypothyroidis with decrease fT4 and fT3. Who signed the informed consent.

Exclusion criteria

Exclusion criteria: Subjects with congenital hypothyroidism, chronic history of hypothyroidism more than 5 yrs and secondary hypothyroidism or tertiary hypothyroidism. subjects with any chronic systemic disorders like cerebrovascular accidents, ischemic heart diseases, uncontrolled diabetes mellitus, uncontrolled hypertension, any active malignancies, chronic renal failure, radiation therapy etc which interrupt the present intervention. Subjects who have undergone thyroid surgery. Pregnant and lactating women. Diagnosed cases of neoplastic conditions, toxic goiter, drug induced hypothyroidism will also be excluded. Who doesn’t sign the informed consent.

Design outcomes

Primary

Measure	Time frame
Pratimarsha nasya with Shakotaka Taila and Krimighnadi Kashaya efficacy in treating primary hypothyroidism with obesity assessing improvement with with diagnostic criteria- Thyroid profile (Serum)TSH, fT3, fT4 and TPO-ab. Waist circumference waist hip ratio Subjective criteria- Clinical signs and symptoms Zulewski’s clinical score for hypothyroidism. Timepoint: 1st Initial Assessment- 0th day 2nd Assessment - 30th day 3rd Assessment - 61st day	—

Measure

Time frame

Pratimarsha nasya with Shakotaka Taila and Krimighnadi Kashaya efficacy in treating primary hypothyroidism with obesity assessing improvement with with diagnostic criteria- Thyroid profile (Serum)TSH, fT3, fT4 and TPO-ab. Waist circumference waist hip ratio Subjective criteria- Clinical signs and symptoms Zulewski’s clinical score for hypothyroidism. Timepoint: 1st Initial Assessment- 0th day 2nd Assessment - 30th day 3rd Assessment - 61st day

—

Secondary

Measure	Time frame
1. Establishing a safe, effective, non levothyroxine hormone supplement dependent formulation in the management of Hypothyroidism with Obesity. 2. Establishing whether intervention is improving the quality of life of Hypothyroidism with Obesity Timepoint: 1st Initial Assessment- 0th day 2nd Assessment - 30th day 3rd Assessment - 61st day	—

Countries

India

Contacts

Public ContactDr Mythrey R C

Rajiv GAndhi University and Health Sciences Bengaluru

mythreyrc@gmail.com86168570803

Outcome results