| CTRI Number |
CTRI/2023/10/058725 [Registered on: 17/10/2023] Trial Registered Prospectively |
| Last Modified On: |
14/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic and Homoeopathic management of Obesity |
|
Scientific Title of Study
|
NOVEL INTEGRATED APPROACH IN THE MANAGEMENT OF OBESITY WITH SPECIAL REFERENCE TO HYPERTRIGLYCERIDEMIA– A RANDOMIZED CONTROL CLINICAL TRIAL |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr ASHOK PATIL MD PhD AYURVEDA |
| Designation |
PROFESSOR AND HOD DEPARTMENT OF SWASTHAVRITTA |
| Affiliation |
KAHERS SHRI BMK AYURVEDA MAHAVIDYALAYA SHAHAPUR BELAGAV |
| Address |
KAHERS SHRI BMK AYURVEDA MAHAVIDYALAYA SHAHAPUR BELAGAVI
C/O DEVKUMAR BIRJE
ADARSH NAGAR
BELAGAVI
KARNATAKA
Belgaum
KARNATAKA
590005
India |
| Phone |
9972583954 |
| Fax |
|
| Email |
ashokpatil.kaher@kleayurworld.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr RINKU PORWAL MD Hom DEMS DIHM CFN |
| Designation |
ASSOCIATE PROFESSOR & HOD DEPT OF FORENSIC MEDICINE AND TOXICOLOGY |
| Affiliation |
KLE HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
KLE HOMEOPATHIC MEDICAL COLLEGE AND HOSPITAL YELLUR BELAGAVI
INCLOVER APPARTMENTS
NANAWADI, BELAGAVI
KARNATAKA
Belgaum
KARNATAKA
590005
India |
| Phone |
09916987766 |
| Fax |
|
| Email |
romagporwal1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR BHAVANA BANDAGI MD Hom |
| Designation |
ASSISTANT PROFESSOR DEPT OF PHYSIOLOGY AND BIOCHEMISTRY |
| Affiliation |
KLE HOMEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
KLE HOMEOPATHIC MEDICAL COLLEGE AND HOSPITAL YELLUR BELAGAVI
SHASTRI NAGAR
6TH CROSS
BELAGAVI
KARNATAKA
Belgaum
KARNATAKA
590005
India |
| Phone |
8884752529 |
| Fax |
|
| Email |
bhavanam2533@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Academy of Higher Education and Research grant for faculty members |
|
|
Primary Sponsor
|
| Name |
KLE ACADEMY FOR HIGHER EDUCATION AND RESEARCH |
| Address |
KLE Academy of Higher Education and Research, Nehru Nagar, Belagavi, |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR ASHOK PATIL |
KAHERs Shri B. M. Kankanawadi Ayurveda Mahavidyalaya, PG Studies |
KAHERs Shri B. M. Kankanawadi Ayurveda Mahavidyalaya, PG Studies, KLE Ayurveda Hospital and MRC, Shahapur, Belagavi- 590003
Belgaum
KARNATAKA |
9972583954
ashokpatil.kaher@kleayurworld.edu.in |
| DR RINKU PORWAL |
KLEU Homoeopathic Medical College and Hospital |
KLEU Homoeopathic Medical College and Hospital Yellur Road Belagavi 590005
Belgaum
KARNATAKA |
9916987766
romagporwal1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics comittee for research on human subjects kahers shri b m kankanwadi ayurved mahavidyalaya and kle ayurved hospital shahpur belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Homoeopathy | homoeopathic fucus vesiculosus and phytolacca berry mother tincture | | 2 | Comparator Arm | Procedure | - | udvartanam, उदà¥à¤µà¤°à¥à¤¤à¤¨à¤®à¥ | (Procedure Reference: charaksamhita, Procedure details: 7 days )
| | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: phytolacca berry, fucus vesiculosus, Reference: boericke materia medica , Route: Oral, Dosage Form: Dravaka, Dose: 20(drops), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: integrated medicine will be administered |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients from either sex with classical sign and symptoms of Obesity Patients of age group 18 to 60 years Patients with BMI greater than 25 kg per m2 to less than 35 kg per m2 Patients with Triglycerides greater than 150mg per dl to lesser than 500 mg per dl |
|
| ExclusionCriteria |
| Details |
Patients having major systemic disorders or other illnesses such as Hypothyroidism PCOS Cushing syndrome Hypersensitivity and Diabetes which interfere with the present study Patients with serious disease limiting life expectancy Pregnancy and lactating mothers Cognitive impairment congenital deformities Not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Novel Integrated approach with Udwartana for 07 days and Individualized Homeopathic remedies administered internally for 30 days will be effective in management of obesity with special respect to Hypertriglyceridemia |
Novel Integrated approach with Udwartana for 07 days and Individualized Homeopathic remedies administered internally for 30 days will be effective in management of obesity with special respect to Hypertriglyceridemia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Udwartana for 07 days will be effective in the management of Obesity with special respect to Hypertriglyceridemia
Individualized Homeopathic remedy for 30 days will be effective in the management of Obesity w r to anthropometric measurements |
30 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
25/10/2023 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Obesity has the deleterious effect both on body and mind. Hence WHO declared it is as global epidemic, giving rise a new term Globesity. If secular trends continue, by 2030 an estimated 38% of the world’s adult population will be overweight and another 20% will be obese. Obesity promotes a cascade of secondary pathologies including Diabetes, hyperlipidemia, hypertriglyceridemia, Inflammation, Thrombosis, Hypertension, insulin resistance, Metabolic syndrome etc. In Ayurveda various modalities and sufficient focus has been given in the management of obesity in form of Rukshan kriya, drug and diet. Guru and Apatarpan is the line of treatment in the management of obesity in Ayurveda. Udwartana has been described and proven to be effective in obesity. Homoeopathy is a holistic and safe way to overcome obesity without any side-effects. It is also proven that Homoeopathic medicines can help to lose weight by improving digestion, absorption, elimination and metabolism. HTG is typically not an isolated abnormality and is frequently associated with other lipid abnormalities and the metabolic syndrome specially in Obesity. So, if goal is to lose fat, we have to reduce the amount of fat stored in our fat cells as the permanent triglyceride form. Existing homeopathic line of treatment is giving a fruitful result in lowering the identified biomarkers in a study subject but the parameters like weight of the body and anthropometric measurements are to be targeted with multiple approach. Ayurveda also has favorable results in lowering the identified bio markers along with body weight and anthropometric measurements. Hence to get rapid desirable effect in the parameters like weight reduction and anthropometric measurement, an integrated approach is designed without interrupting the core treatment principle of both the medical discipline. The treatment protocol is tailored to minimize drug interaction in the form of Udwartana kriya (external intervention) and individualized homeopathic remedies (Internal intervention). Based on the above facts, to get a way through the burning issue of obesity the present study on “NOVEL INTEGRATED APPROACH IN MANAGEMENT OF OBESITY WITH SPECIAL RESPECT TO HYPERTRIGLYCERIDEMIA– A RANDOMIZED CONTROL CLINICAL TRIAL†has been planned. |