Study To Evaluate The Efficacy Of Trikatvadhya Lauha And Lifestyle Modification In Management Of Sthaulya (Overweight and Obesity)

Randomized Double Blind Placebo Controlled Clinical Trial To Evaluate The Efficacy Of Trikatvadya Lauha And Lifestyle Modification In Sthaulya (Overweight and Obesity)

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/05/053158

Enrollment

Registered

2023-05-26

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-29

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

Conditions

Health Condition 1: E660- Obesity due to excess calories

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient in the age group of 18 to 60 years of either sex. 2. Patient with BMI ranging from 23 and above 25 kg/m2 (Overweight and Obesity as per Asia-pacific guidelines). 3.Patient having classical signs and symptoms of Sthaulya, if any 4.Overweight and obese individuals having Subclinical hypothyroidism. 5.Known cases of Type 2 DM having fasting blood sugar level less than 200 mg/dl (Patients on metformin will be included if they are consuming it for more than one year

Exclusion criteria

Exclusion criteria: 1. Patient having BMI below 23 kg/m2 and above 25 kg/m2 2. Patients with clinical and overt hypothyroidism 3.Patients having corticosteroids, anti-convulsant, anti-psychotic, anti-depressants, anti-anxiety drugs 4. Patients with chronic disorders like nephrotic syndrome, renal failure, heart failure, Interstitial Lung Disease, chronic liver disease, autoimmune disorders and other serious diseases 5.Patients with uncontrolled hypertension (more than 160/100 mm of Hg), uncontrolled diabetes (fasting blood sugar level more than 200 mg/dl) and other endocrine disorders 6. Pregnant women and lactating mother and females of child bearing age willing to conceive during trial period. 7. Patient having past history of MI and unstable angina

Design outcomes

Primary

Measure	Time frame
Changes in weight and BMI from the baseline value at the end of 60 days. Timepoint: Changes in weight and BMI from the baseline value at the end of 60 days.	—

Secondary

Measure	Time frame
1. Changes in other anthropometric parameters (waist circumference, Waist : Hip ratio, skin fold thickness) from the base line value at the end of 60 days. 2.Changes in hs CRP value (obesity related inflammatory marker) from the baseline value at the end of 60 days. 3. Changes in vLDL and Triglyceride value from the baseline value at the end of 60 days. 4. Changes in FBS value from the baseline value at the end of 60 days. Timepoint: at the end of 60 days	—

Measure

Time frame

1. Changes in other anthropometric parameters (waist circumference, Waist : Hip ratio, skin fold thickness) from the base line value at the end of 60 days. 2.Changes in hs CRP value (obesity related inflammatory marker) from the baseline value at the end of 60 days. 3. Changes in vLDL and Triglyceride value from the baseline value at the end of 60 days. 4. Changes in FBS value from the baseline value at the end of 60 days. Timepoint: at the end of 60 days

—

Countries

India

Contacts

Public ContactDr Pooja Lekhak

National Institute of Ayurveda

joshirk1964@gmail.com9414322297

Outcome results