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CTRI Number  CTRI/2019/02/017426 [Registered on: 04/02/2019] Trial Registered Prospectively
Last Modified On: 01/02/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy and safety of Lekhan Basti and Navak Guggul in Sthaulya (Obesity) using biochemical and genetic markers 
Scientific Title of Study   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 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
DCP/AYU/2018/04  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Renuka Munshi 
Designation  Associate Professor and Incharge 
Affiliation  TN Medical College & BYL Nair Hospital 
Address  5th Floor, Department of Clinical Pharmacology, TNMC & BYL Nair Hospital, Mumbai Central, Mumbai

Mumbai
MAHARASHTRA
400008
India 
Phone  02223014713  
Fax    
Email  renuka.munshi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Renuka Munshi 
Designation  Associate Professor and Incharge 
Affiliation  TN Medical College & BYL Nair Hospital 
Address  5th Floor, Department of Clinical Pharmacology, TNMC & BYL Nair Hospital, Mumbai Central, Mumbai


MAHARASHTRA
400008
India 
Phone  02223014713  
Fax    
Email  renuka.munshi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Renuka Munshi 
Designation  Associate Professor and Incharge 
Affiliation  TN Medical College & BYL Nair Hospital 
Address  5th Floor, Department of Clinical Pharmacology, TNMC & BYL Nair Hospital, Mumbai Central, Mumbai


MAHARASHTRA
400008
India 
Phone  02223014713  
Fax    
Email  renuka.munshi@gmail.com  
 
Source of Monetary or Material Support  
TN Medical College & BYL Nair Hospital, Mumbai 
 
Primary Sponsor  
Name  TN Medical College BYL Nair Hospital 
Address  G building, 5th Floor, Department of Clinical Pharmacology, Mumbai Central, Mumbai 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Renuka Munshi  Department of Clinical Pharmacology  5th Floor, G Bldg., TN Medical College And BYL Nair Hospital, Mumbai Central, Mumbai
Mumbai
MAHARASHTRA 
2223014713

renuka.munshi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Academic Research Projects  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E668||Other obesity,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lekhan Basti  Lekhana basti will be administered through the ano-rectal route for 3 cycles, each cycle lasting 15 days 
Comparator Agent  Navak guggulu  participants will be provided with Navak guggul oral tablets 1 gm to be taken twice a day with honey as an adjuvant for the period of 6 months 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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)
 
 
ExclusionCriteria 
Details  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, Cushing‘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 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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 treatment 
Day 0, Day 45,Day 90, Day 135, Day 165 and Day 195 
 
Secondary Outcome  
Outcome  TimePoints 
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 treatment 
Day 0, Day 135 and Day 195 
 
Target Sample Size   Total Sample Size="256"
Sample Size from India="256" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   11/02/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Publication will be done after completion of the project 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Obesity is the one of the oldest and globally spread metabolic disorder.  According to WHO, in 2014 globally 600 million people were Obese. Obesity is associated with various diseases, particularly cardiovascular diseases, diabetes mellitus type 2 and obstructive sleep apnea, certain type of cancer, osteoarthritis and asthma. As a result, obesity has been found to reduce life expectancy.

Obesity also has its references described in the most ancient science Ayurveda and termed as Sthaulya. Sthaulya or Obesity is termed into the Asthanindit purusha means Eight Condemned Disease. Human beings in Ayurveda comprises of seven dhatus, Three Mala and Three Dosha. Out of all dhatus, Meda dhatu is the fourth in sequence after the first three viz. Rasa, Rakta, Maansa. Excessive production of this Meda dhatu leads to abnormal accumulation and deposition of abnormal fat throughout the human body.

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

Treatment options for obesity include medications that curb appetite, such as Orlistat and Lorcaserin, but the drugs can cause side effects like cramping, diarrhea, headaches, dizziness and nausea. Although surgical techniques like liposuction & bariatric surgery are available, potential complications following these procedures is still 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 and dental problems are being faced by people after bariatric surgery. 

According to Ayurveda, management of obesity includes both internal and external routes of administration of medications i.e. Shamana Chikitsa and Shodhana Chikitsa respectively.  Shamana means alleviation while Shodhana means elimination. Shamana methods mitigate the disease and its symptoms while Shodhana methods aim at elimination of the cause of the disorder. Administration of Shaman Chikitsa takes longer duration to demonstrate efficacy whereas Shodhana chikitsa, which is also termed as Panchakarma chikitsa, gives quicker and detoxifying effect that lasts for longer periods.

A previous pilot study was carried out at our centre to assess the immunological & metabolic responses to a therapeutic course of basti in obesity. We found that Ayurvedic basti (enema) treatment is safe and it modulates immune responses by regulating proinflammatory cytokines, immunoglobulins and functional properties of T-cells. These changes were associated with reduction in the body weight which was maintained even after three months. Naval Guggul & Lekhan basti both are used in the treatment regimen of Obesity. So we proposed this study to compare the efficacy of Lekhan therapy (treatment of Obesity) when administered by 2 different therapeutic modalities viz Lekhan basti and Navak Guggul & to study changes in specific biochemical markers (leptin & Ghrelin) and genetic markers between the 2 study groups at the end of treatment. 

A multidisciplinary research effort involving a combination of clinical, biochemical and omics approaches appears mandatory to increase knowledge in the complexity of biological traits and processes associated with obesity. Through probing of the transcriptional activity of peripheral blood, the techniques allowing systematic analysis of gene expression may prove useful at identifying master genes and regulatory networks involved in human obesity and related disorders.

To test this hypothesis, in the present study we have planned to carry out transcriptional profiling of peripheral blood from obese participants before and after undergoing Shamana therapy and Shodhana therapy. Also, in this clinical Study, we would like to compare the efficacy of Lekhan Basti as Shodhana Chikitsa and Navak Guggul as Shamana Chikitsa in the management of Sthaulya (Obesity). Such integrative approach will facilitate the present quest for evidence based Ayurveda.

 
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