Clinical trial for management of metabolic manifestations of Primary hypothyroidism patients due to Ras dushti.

Critical Study On Anubandhya- Anubandh Siddhanta And Management of Metabolic Manifestations due to Ras Dushti in Primary Hypothyroidism patients in purview of Pradhaanaprashame prashamoashamyatastathaa - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/070483

Enrollment

Registered

2024-07-11

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: PCS-

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient taking low dose of conventional medicine (up to 50 mcg) (Stratification as per dose will be done to observe the effect in different doses of conventional medicine i.e. thyroxine). 2. Adults of age group 18 to 50 year irrespective of race, gender, religion, caste, occupation, education. 3. Patients who are willing to give written consent. 4. Patients with 1 year of chronicity of disease (including recurrence). 5. Patients with classical signs and symptoms of disease. (as per ICD 10 E03.9) [Decreased basal metabolic rate, fatigue and lethargy, sensitivity to cold, and menstrual disturbances; untreated it progresses to myxedema weight gain, constipation and dry skin.]

Exclusion criteria

Exclusion criteria: 1. Patients who are under high dose (i.e. 75mcg or more) of Conventional Medications because those patients may need additional intervention along with the trial drug to achieve satisfactory result in short duration of trial. 2. Individuals with other comorbidities like hypertension, diabetes mellitus, epilepsy, tuberculosis, carcinoma, and any other severe illness. 3. Patients with thyroiditis and postoperative Primary hypothyroidism. 4. Pregnant , postpartum and lactating women. 5. Individuals who have undergone Panchakarma procedures.

Design outcomes

Primary

Measure	Time frame
1)Assessment of effect of treatment on TSH , T3 and T4 will be assessed before treatment, after completion of trial and after Follow up. 2) Assessment of effect of treatment on metabolic manifestations of Primary hypothyroidism ,as mentioned above will be assessed by prepared questionnaire and on Day 0 i.e. before initiation of treatment, 15th Day, 30th Day i.e. after completion of trial and after follow up i.e. 60 days Timepoint: 1)Assessment of effect of treatment on TSH , T3 and T4 will be assessed before treatment, after completion of trial and after Follow up. 2) Assessment of effect of treatment on metabolic manifestations of Primary hypothyroidism ,as mentioned above will be assessed by prepared questionnaire and on Day 0 i.e. before initiation of treatment, 15th Day, 30th Day i.e. after completion of trial and after follow up i.e. 60 days	—

Measure

Time frame

1)Assessment of effect of treatment on TSH , T3 and T4 will be assessed before treatment, after completion of trial and after Follow up. 2) Assessment of effect of treatment on metabolic manifestations of Primary hypothyroidism ,as mentioned above will be assessed by prepared questionnaire and on Day 0 i.e. before initiation of treatment, 15th Day, 30th Day i.e. after completion of trial and after follow up i.e. 60 days Timepoint: 1)Assessment of effect of treatment on TSH , T3 and T4 will be assessed before treatment, after completion of trial and after Follow up. 2) Assessment of effect of treatment on metabolic manifestations of Primary hypothyroidism ,as mentioned above will be assessed by prepared questionnaire and on Day 0 i.e. before initiation of treatment, 15th Day, 30th Day i.e. after completion of trial and after follow up i.e. 60 days

—

Secondary

Measure	Time frame
1. Assessment of improvement in the Quality of Life. This will be assessed with the help Thypro39 scale at the end of trial.Timepoint: 60 days	—

Countries

India

Contacts

Public ContactDr Mahesh Vyas

All India institute of Ayurveda

kamalkumar324@gmail.com9785031320

Outcome results