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
|
|
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
|
|
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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