Efficacy and safety of Lekhan Basti and Navak Guggul in Sthaulya (Obesity) using biochemical and genetic markers

An open, controlled, comparative clinical study to assess the efficacy and safety of Lekhan Basti and Navak Guggul in the management of Sthaulya (Obesity) with special regard to biochemical and genetic marker

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/02/017426

Enrollment

256

Registered

2019-02-04

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: E668- Other obesity

Interventions

Intervention1: Lekhan Basti: Lekhana basti will be administered through the ano-rectal route for 3 cycles, each cycle lasting 15 days Control Intervention1: Navak guggulu: participants will be provide

Eligibility

Inclusion criteria

Inclusion criteria: 1. BMI: Between 28-32.9 / Grade I obesity 2. Waist-Hip Ratio greater than the normal reference range as per WHO (Men > 0.90 and Women > 0.85)

Exclusion criteria

Exclusion criteria: 1.Patients with Grade II/Grade III obesity (BMI score between 33 to 38 or >38) 2.Patients with past history of major cardiac conditions like acute coronary syndrome, Myocardial Infarction, cardiac arrhythmias and/or cardiac failure in the last 6 months 3.Patients with severe &/or uncontrolled medical conditions like Diabetes mellitus (FBS > 200mg/dl) and hypertension (BP >160/100 mm Hg), endocrine disorders (Hyperthyroidism, hypothyroidism, Cushingâ??s syndrome), malignancies and/or any other clinically significant medical condition, which the investigator believes, will contraindicate his/her inclusion in the study. 4.Patients with history of Immuno-compromised status (HIV, Hepatitis B & C etc.) 5.Patients with any ano-rectal conditions like bleeding piles, fistula, fissure etc. 6.Those receiving any other concomitant drugs that could confound the efficacy evaluation. 7.Pregnant and/or lactating women 8.Alcoholics and/or drug abusers. 9.Any other condition which the Study Investigators think may jeopardize the study

Design outcomes

Primary

Measure	Time frame
1.Change in body weight among 4 study groups at the end of treatment. 2.Change in anthropometric measurements among 4 study groups at the end of treatmentTimepoint: Day 0, Day 45,Day 90, Day 135, Day 165 and Day 195	—

Secondary

Measure	Time frame
1.Change in the Ayurvedic symptom score among 4 study groups at the end of treatment. 2.Change in the biochemical markers among 4 study groups at the end of treatment. 3.Change in the genetic markers among 4 study groups at the end of treatment. 4.Change in the Quality of Life score among 4 study groups at the end of treatmentTimepoint: Day 0, Day 135 and Day 195	—

Countries

India

Contacts

Public ContactDr Renuka Munshi

TN Medical College & BYL Nair Hospital

renuka.munshi@gmail.com02223014713

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026