| CTRI Number |
CTRI/2020/08/027196 [Registered on: 18/08/2020] Trial Registered Prospectively |
| Last Modified On: |
19/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Slim honey in Obesity |
|
Scientific Title of Study
|
An Open Label, Single Arm, Prospective Clinical Study To Evaluate Efficacy And Safety Of Slim Honey In Obese Subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nalini R Humaney |
| Designation |
HOD MEDICINE |
| Affiliation |
NKP Salve Institute of Medical Sciences and Lata Mangeshkar Hospital |
| Address |
Department of Medicine, NKP Salve Institute of Medical Sciences and Lata Mangeshkar Hospital
Digdoh Hills, Near CRPF Rd, Near Priyadarshani College, Hingna, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
|
| Fax |
|
| Email |
drnalini.humaney@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Puneet Mittal |
| Designation |
Director- IB, Clinical Research |
| Affiliation |
Mittal Ayurved Sansthan |
| Address |
121 B, Mansarovar Industrial Estate Extension.,Panchli Khurd, Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
|
| Fax |
|
| Email |
puneetmittal@mittalayurved.com |
|
Details of Contact Person
Public Query
|
| Name |
Puneet Mittal |
| Designation |
Director- IB, Clinical Research |
| Affiliation |
Mittal Ayurved Sansthan |
| Address |
121 B, Mansarovar Industrial Estate Extension.,Panchli Khurd, Meerut
UTTAR PRADESH
250005
India |
| Phone |
|
| Fax |
|
| Email |
puneetmittal@mittalayurved.com |
|
|
Source of Monetary or Material Support
|
| MITTAL AYURVED SANSTHAN
121-B, Mansarovar Industrial Estate Ext. Inside Vishvakarma
Industrial Estate, Baghpat Road, Meerut-250002[INDIA] |
|
|
Primary Sponsor
|
| Name |
Royal Bee Natural Products Pvt Ltd |
| Address |
Sahibabad, S-61, Loni Road, Mohan Nagar, site 2, sahibabad, Ghaziabad, Uttar Pradesh 201007 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Nalini R Humaney |
NKP SALVE INSTITUTE OF MEDICAL SCIENCES & LATA MANGESHKAR HOSPITAL |
First floor, Department of Medicine, Digdoh Hills, Hingna Road, Nagpur
Nagpur
Nagpur
MAHARASHTRA |
8937015757
drnalini.humaney@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE NKP SALVE INSTITUTE OF MEDICAL SCIENCES AND LATA MANGESHKAR HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Slim Honey |
10 gm (1Tsp) of Slim Honey twice a day Morning and Evening for a period of 45 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and/or female volunteers aged between 18 to 65 years both inclusive.
2. BMI (>) greater than or equal to 25 kg/m2 and less than or equal to (<) 34.9 Kg/m2.
3. Willing to do exercise for a span of 30 minutes daily for at least5 days in a week.
4. Willing to follow diet advised by investigator
5. Willing to come for regular follow-up visits. |
|
| ExclusionCriteria |
| Details |
1. Intake of over the counter weight loss agents, centrally acting appetite suppressants or prior surgery for obesity in the previous three months.
2. History of pathophysiologic/genetic syndromes associated with obesity (Cushing’s syndrome, Turner’s syndrome, and Parder- Willi Syndrome).
3. Alcoholics and subjects with substance abuse.
4. Subject with evidence of malignancy
5. Subjects having history of underlying inflammatory arthropathy, septic arthritis, inflammatory joint disease, gout, pseudo gout, Paget’s disease, joint fracture, acromegaly, fibromyalgia, rheumatoid arthritis.
6. Subjects having history of coagulopathies, cardiovascular diseases, asthma.
7. Subjects with HbAlc> 7 % and poorly controlled diabetes mellitus, poorly controlled hypertension.
8. TSH > 10 mIU/L and T3 and T4 higher than normal range.
9. Pregnant and lactating women.
10. Subjects with hepatic and renal failure.
11. Subjects on prolonged (> 6 weeks) medication with corticosteroids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study.
12. Subjects with hypersensitivity to any one ingredient of the drugs.
13. Subjects who have participated in other trial within last 3 months.
14. Any other condition which the principal investigator thinks may jeopardize the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in body weight (kg) |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in anthropometric measurements |
6 weeks |
| Change in quality of life |
6 weeks |
| Tolerability of drugs |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/08/2020 |
| Date of Study Completion (India) |
01/12/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study is designed as Open label, prospective, interventional and observational study. Subject will be assigned to receive Slim Honey. Parameters of anthropometric measurements and quality of life questionnaires will be assessed. Safety parameters like hematology and biochemistry will be assessed if required. AE/SAE will be recorded during the conduct of the study.The study will enroll subjects of age group 18 to 65 years. The regulatory approvals are taken care by MGCTS (Mittal Global Clinical Trial Services). A total of 30 cases will be enrolled in one group with BMI between 25-34.9 Kg/m2. All the subjects will receive test drug Slim Honey |