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

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 Sthaulyaor 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 Shodhanamethods 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.