To study the effect of Triphaladi Guggulu vati and its add on effect with tablet Thyroxine in Hypothyroidism

Randomized control trial to evaluate the efficacy of Triphaladi Guggulu Vati and its add on effect with Tablet Thyroxin in Hypothyroidism.

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/03/051212

Enrollment

126

Registered

2023-03-31

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-01

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

Conditions

Health Condition 1: E02- Subclinical iodine-deficiency hypothyroidism

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1) Age - 18 to 60yrs 2) Gender -both male and female patients will be selected irrespective of religion and economic status. 3) Known case of Hypothyroidism initiated on treatment not more than 5 years and newly Diagnosed case of Hypothyroidism By clinical parameters, Zulewskiâ??s Clinical Score and Thyroid Function Test, FreeT4, and TSH ( >5.5 micro IU/ml)

Exclusion criteria

Exclusion criteria: 1) Patients Suffering From Co-Morbid or Life Threatening Elements. 2)Known Case of Congenital Hypothyroidism or Anatomical Deformity Related To Thyroid Gland 3)Known Case of Thyroid Neoplasia. 4)Known Case of Progressive Case of Myxoedema Coma. 5)Known Case of Infiltrative Disorders like Sarcoidosis Etc. 6)Individual Suffering From Immune Compromised Diseases or Patients on Immunocompressive Drugs. 7)Pregnancy 8)Known Case of Hypothyroidism Caused Due to the Administration of Chemotherapy Radiotherapy Post I -131 Therapy And Post Thyroidectomy

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of Triphaladi Guggulu Vati alone and as add on in Symptoms, T3, T4, TSH, and free T4 in Hypothyroidism.Timepoint: 60 days	—

Secondary

Measure	Time frame
To compare the efficacy of Triphaladi Guggulu Vati alone and as an add on with Tablet Thyroxin in Hypothyroidism on the basis of 1) subjective parameters- Zulewskiâ??s clinical score Loss of appetite Weight gain ,Puffiness,Constipation Amenorrhea(Interval between two cycles) Quantity of menstrual flow Duration of menstrual blood Edema,Dry and coarse skin Breathlessness,Debility(Weakness) Fatigue,Somnolence (Duration of sleep ) Muscle ache ,Hair fall Hoarseness of voice 2) objective-biochemical parameter T3 ,T4 ,TSH, FREE T4. Timepoint: 60 days	—

Measure

Time frame

To compare the efficacy of Triphaladi Guggulu Vati alone and as an add on with Tablet Thyroxin in Hypothyroidism on the basis of 1) subjective parameters- Zulewskiâ??s clinical score Loss of appetite Weight gain ,Puffiness,Constipation Amenorrhea(Interval between two cycles) Quantity of menstrual flow Duration of menstrual blood Edema,Dry and coarse skin Breathlessness,Debility(Weakness) Fatigue,Somnolence (Duration of sleep ) Muscle ache ,Hair fall Hoarseness of voice 2) objective-biochemical parameter T3 ,T4 ,TSH, FREE T4. Timepoint: 60 days

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Countries

India

Contacts

Public ContactDR RAHUL ISHWARLAL DESAI

MAMs SUMATIBHAI SHAH AYURVEDA , MAHAVIDYALAYA,HADAPSAR ,PUNE

drsachinkumarpatil@yahoo.com9822603608

Outcome results