| CTRI Number |
CTRI/2024/04/065700 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
To Evaluate the Safety of an Ayurvedic Water Based Juice in Healthy Volunteers |
|
Scientific Title of Study
|
An Open Label Study to Evaluate the Efficacy and Safety of an Ayurvedic Water Based Juice Formulation on Weight Management in Healthy Volunteers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TG/CLI/084, Version 1.0, 08 Mar 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rachana K L |
| Designation |
Principal Investigator |
| Affiliation |
TrialGuna Private Limited |
| Address |
467, 2nd floor, 1st Main Rd, Royal Country, 8th Phase, Gottigere, Bengaluru, Karnataka
Bangalore
KARNATAKA
560083
India |
| Phone |
9739958095 |
| Fax |
|
| Email |
dr.klr.lucky@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rachana K L |
| Designation |
Principal Investigator |
| Affiliation |
TrialGuna Private Limited |
| Address |
467, 2nd floor, 1st Main Rd, Royal Country, 8th Phase, Gottigere, Bengaluru, Karnataka
KARNATAKA
560083
India |
| Phone |
9739958095 |
| Fax |
|
| Email |
dr.klr.lucky@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Meena Dalal |
| Designation |
CRO representative |
| Affiliation |
TrialGuna Private Limited |
| Address |
467, 2nd floor, 1st Main Rd, Royal Country, 8th Phase, Gottigere, Bengaluru, Karnataka
Bangalore
KARNATAKA
560083
India |
| Phone |
09972636265 |
| Fax |
|
| Email |
meena@trialguna.com |
|
|
Source of Monetary or Material Support
|
| Sesa Care Private Limited
Hamilton, B-Wing, 4th Floor, Hiranandani Business Park,
Hiranandani Estate, Ghodbunder Road, Thane (W), Maharashtra- 400607, India |
|
|
Primary Sponsor
|
| Name |
Sesa Care Private Limited |
| Address |
Hamilton, B-Wing, 4th Floor, Hiranandani Business Park, Hiranandani Estate, Ghodbunder Road, Thane (W), Maharashtra - 400607, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rachana K L |
TrialGuna Private Limited |
467, 2nd floor, 1st Main Rd, Royal Country, 8th Phase, Gottigere, Bengaluru, Karnataka
Bangalore
KARNATAKA |
9739958095
dr.klr.lucky@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pranav Diabetes Center Ethics Committee |
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 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Sesa Ayurvedic ActivSlim Juice, Reference: NA, Route: Oral, Dosage Form: Swaras/ Juice, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1) Subjects of either sex between 25 to 45 years of age.
2) Subject with BMI range (26-32).
3) Ability of the subject to understand the risks/benefits of the protocol
4) Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, or double-barrier and have a negative pregnancy test at the Screening Visit. Female subjects of non-childbearing potential must be amenorrhoeic for at least one year or had a hysterectomy and/or bilateral oophorectomy.
5) Willingness to participate in a walking-exercise program (5 days a week, 30 min per day) with the scheduled timing per week during the course of the study.
6) Subject agrees to consume a vegetarian/non-vegetarian diet of approximately 2,000 kcal/day (17% protein, 25% Fat and 58% carbohydrate).
7) Subjects willing to go for DEXA analysis during the study.
8) Subjects willing to get photographed from front and side pose in similar or preferably same set of clothes before and after study. Subject anonymity will be maintained in photographs with an eye strip.
9) Subject should be available for duration of study period (three months).
10) Subjects agree to come to site in fasting state for their weight measurements and other laboratory parameters examination in all the scheduled visits.
11) Subject using other therapies for weight management including physiotherapy/ occupational therapy agrees to discontinue these therapies during this study.
12) Subject agrees not to start any new therapies for weight loss during the study.
13) Subjects agree to maintain the activity dairy
14) Willing to give written informed consent and willing to comply with trial protocol. |
|
| ExclusionCriteria |
| Details |
1)Subjects suffered from intractable obesity, had defined weight limits or had experienced any recent, unexplained weight loss or gain.
2)Subjects having history of underlying inflammatory arthropathy, septic arthritis, gout, inflammatory joint disease, joint fracture or rheumatoid arthritis.
3)Subjects with hyperuricemia, thyroid disease, abnormal values of liver or kidney functioning or abnormal findings on complete blood count, and hypertension.
4)Subject with hyperuricemia, thyroid disease, abnormal liver or kidney function test, abnormal findings on complete blood count, and hypertension.
5)Subjects having history of asthma, cardiovascular diseases, coagulopathies, diabetes except other than the subject having the pre-diabetes condition with the fasting blood glucose or random blood glucose ≥ 140-199 mg/dl.
6)Subjects having history of high alcohol intake.
7)Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent and increase the risk of adverse events or interfere with study assessments.
8)Subjects, who are pregnant, breast feeding or planning to become pregnant during the study.
9)Immunocompromised subjects or subjects with steroids or immunomodulators.
10)Patients of vulnerable group.
11)Any other condition that, in the opinion of the investigator, would adversely affect the subject’s ability to complete the study or its measures.
12)Subjects participated in any investigational study medication within thirty 30 days prior to screening.
13)Subjects known allergy to compounds of investigational product. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To measure the total body weight loss by x%
2) To record the BMI
3) To evaluate the body fat composition by Dual Energy X-ray Absorptiometry DEXA analysis
|
Day 1, Day 30, Day 60 and Day 90
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To assess the waist circumference.
2) To record the waist to hip ratio
3) Skin fold thickness measured by skinfold caliper
4) To evaluate the change in Impact of Weight on Quality-of Life Questionnaire-Lite survey IWQOL-Lite.
5) Monitor any changes in haematological, liver and kidney function parameters from baseline to the end of
the study.
6) To monitor treatment-related adverse events during the study period.
7) To record photographic evidence. |
Day 1 and Day 90 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
29/04/2024 |
| 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="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 represents a medical state of excess body fat accumulation as a consequence of
energy imbalance between calories consumed and calories disbursed.
Obesity is associated with a host of potential comorbidities such as type II diabetes mellitus,
hypertension, coronary heart disease, osteoarthritis, stroke, depression, non-alcoholic fatty
liver disease, infertility (women), erectile dysfunction (men), risk of stillbirth, gallbladder
disease, obstructive sleep apnoea, gastroesophageal reflux disease, some cancers
(endometrial, breast, and colon),
1 etc. Weight management refers to the process of making long-time lifestyle changes to maintain
a healthy body weight based on age, height, and sex. Weight management includes eating a
healthy, balanced diet, and increasing levels of physical activity.3
Ayurveda, one among the popular complementary alternative medicine has a more extensive
and holistic treatment of chronic illness such as obesity.1 Ayurvedic ActivSlim juice from Sesa
wellness helps in the weight management by boosting metabolism, burning excessive fat,
supports healthy lipid levels, and building immunity. The Ayurvedic ActivSlim juice has been
made with a unique blend of 14 Ayurvedic herbs. This study aims to evaluate the efficacy and safety of an Ayurvedic water based slim juice
formulation (Ayurvedic ActivSlim juice) on weight management. |