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

Phase 4

Not yet recruiting

Conditions: Other obesity,

Registration Number: CTRI/2019/02/017426

Lead Sponsor: TN Medical College BYL Nair Hospital

Brief Summary: Obesity is the one of the oldestand globally spread metabolic disorder. According to WHO, in 2014 globally 600 million people wereObese. Obesity is associated with various diseases, particularly cardiovasculardiseases, diabetes mellitus type 2 and obstructive sleep apnea, certain type ofcancer, osteoarthritis and asthma. As a result, obesity has been found toreduce life expectancy.

Obesity also has its referencesdescribed in the most ancient science Ayurveda and termed as *Sthaulya. Sthaulya* or Obesity is termedinto the *Asthanindit purusha* means Eight Condemned Disease. Human beings in Ayurveda comprises of sevendhatus, Three Mala and Three *Dosha*.Out of all *dhatus, Meda dhatu* is thefourth in sequence after the first three viz. *Rasa*, *Rakta*, *Maansa.* Excessive productionof this *Meda dhatu* leads to abnormalaccumulation and deposition of abnormal fat throughout the human body.

Common *Hetus* (reasons) for *Sthaulya*or *Medoroga* are excessive food intakewhich are of *Guru* and *Snigdha Guna*,*Madhur* Rasa, Sheet *Vipaka*, lack of *Vyayama*, *Divaswaapa* (sleepingduring the day), *Achinta* and *beej* dosha.4 Today, modernscience also classifies Obesity in a manner similar to *Medoraga* described in Ancient Ayurveda texts wherein Obesity is amedical condition in which excess body fat has accumulated to the extent thatit may have a negative effect on health.

Treatment options for obesityinclude medications that curb appetite, such as Orlistat and Lorcaserin, butthe drugs can cause side effects like cramping, diarrhea, headaches, dizzinessand nausea. Although surgical techniques like liposuction & bariatricsurgery are available, potential complications following these procedures isstill a hindering issue. Dumping Syndrome, dehydration, gall bladder stones,dysphagia, indigestion, kidney stones, hair loss, incisional hernia,malnutrition, ulcers, intolerance to certain foods, beverages & drugs anddental problems are being faced by people after bariatric surgery.

According to Ayurveda, managementof obesity includes both internal and external routes of administration ofmedications *i.e*. *Shamana Chikitsa* and *ShodhanaChikitsa* respectively. Shamana meansalleviation while *Shodhana* meanselimination. *Shamana* methods mitigatethe disease and its symptoms while *Shodhana*methods aim at elimination of the cause of the disorder. Administration of *Shaman Chikitsa* takes longer duration todemonstrate efficacy whereas *Shodhana chikitsa*,which is also termed as *Panchakarmachikitsa*, gives quicker and detoxifying effect that lasts for longerperiods.

A previous pilot study wascarried out at our centre to assess the immunological & metabolic responsesto a therapeutic course of basti in obesity. We found that Ayurvedic basti(enema) treatment is safe and it modulates immune responses by regulatingproinflammatory cytokines, immunoglobulins and functional properties ofT-cells. These changes were associated with reduction in the body weight whichwas maintained even after three months. Naval Guggul & Lekhanbasti both are used in the treatment regimen of Obesity. So we proposed thisstudy to compare the efficacy of Lekhan therapy (treatment of Obesity) whenadministered by 2 different therapeutic modalities *viz **Lekhan basti*** and ***NavakGuggul*** & to study changes in specific biochemical markers (leptin& Ghrelin) and genetic markersbetween the 2 study groups at the end of treatment.

Amultidisciplinary research effort involving a combination of clinical,biochemical and omics approaches appears mandatory to increase knowledge in thecomplexity of biological traits and processes associated with obesity. Through probing of the transcriptional activity of peripheral blood, thetechniques allowing systematic analysis of gene expression may prove useful atidentifying master genes and regulatory networks involved in human obesity andrelated disorders.

Totest this hypothesis, in the present study we have planned to carry outtranscriptional profiling of peripheral blood from obese participants beforeand after undergoing *Shamana* therapyand *Shodhana* therapy. Also, in thisclinical Study, we would like to compare the efficacy of *Lekhan Basti* as *ShodhanaChikitsa* and *Navak Guggul* as *Shamana Chikitsa* in the management of *Sthaulya* (Obesity). Such integrativeapproach will facilitate the present quest for evidence based Ayurveda.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 256

Inclusion Criteria

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1): Department of Clinical Pharmacology
🇮🇳
Mumbai, MAHARASHTRA, India
Department of Clinical Pharmacology
🇮🇳Mumbai, MAHARASHTRA, India
Dr Renuka Munshi
Principal investigator
2223014713
renuka.munshi@gmail.com