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| Name | Class |
|---|---|
| Collagen Lifesciences Private Limited | UNKNOWN |
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A proof of science clinical study with randomized, four-arm, comparative, single-blind, within the arm - Dose-Response Study to evaluate the safety and efficacy of different collagen peptide-containing test treatments in adult human subjects.
The dose-response will be evaluated for the effectiveness of each test treatment in three different dosages that is 2.5 g Versus 5 g Versus 10 g.
22 subjects will be enrolled per dose per test treatment to complete 20 subjects per dose per test treatment.
A proof of science clinical study with randomized, four-arm, comparative, single-blind, within the arm - Dose-Response Study to evaluate the safety and efficacy of different collagen peptide-containing test treatments in adult human subjects.
The dose response will be evaluated for the effectiveness of each test treatment in three different dosages that is 2.5 g Versus 5 g Versus 10 g.
22 subjects will be enrolled per dose per test treatment to complete 20 subjects per dose per test treatment.
There are four different test treatments as mentioned below will be tested during study.
Considering proof of science study, a sufficient number of adult subjects with an age group of 30 - 50 years old (i) having mild to moderate crows' feet wrinkles near to eye area and (ii) mild to moderate joints pain, swelling, stiffness and decreased range of motion (iii) having complaints of hair fall, decreased hair growth, brittle nails will be recruited/enrolled.
In Bovine Arm, out of 66 subjects, a few subjects with osteoarthritis patients having present complaints of pain and stiffness in joints will be enrolled.
The collagen peptides effects of all 4 variants will be evaluated in enrolled subjects with mild to moderate acne.
The potential subjects will be screened as per the inclusion & exclusion criteria only after obtaining written informed consent from the subjects. The subjects will be instructed to visit the facility as per the below visits.
Subjects will be pre-screened by the screening department of NovoBliss Research. Subjects will be telephonically contacted by recruiting department prior to the enrolment visit. Subjects will be instructed during screening (prior to enrolment) not to wear any facial makeup during study visits to the facility. The study will be conducted in four different groups considering four different arms of test treatments.
Assessment of safety and efficacy parameters will be done before test treatment usage on Day 1, and will be compared with after test treatments usage on Day 10 (+2 Days), Day 30 (+2 Days), and Day 60 (+2 Days) within treatments and between treatments, between three dosages as listed-below.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VEGCOL™️ (Veg Collagen Peptide) | Experimental | Mode of Usage: 1 scoop/sachet daily Route of Administration: Oral administration with a glassful (approx. 250 mL) of water VEGCOL helps in providing the necessary nutrition needed for the body to produce collagen. Vegan collagen gives a lighter feel on consumption compared to any other collagen and increases the elasticity of the skin and makes skin supple. VEGCOL has more amino acids than animal derived Collagen which makes it very ideal to consume not only in Vegetarian populated countries like in India but around the world. Pepsin, a digestive enzyme, is added to help structure the building blocks into collagen molecules with the exact structure of human collagen. |
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| PROCOL (Bovine Collagen Peptide) | Experimental | Bovine collagen is a naturally occurring protein present in the connective tissue, bones, cartilage, and hides of cows. Mode of Usage: 1 scoop/sachet daily Route of Administration: Oral administration with a glassful (approx. 250 mL) of water. |
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| AQUACOL (Fish | Marine Collagen Peptide) | Experimental | Marine Collagen is made from Fish Skin which delays the signs of aging such as wrinkles, Joint issues and weakness. Mode of Usage: 1 scoop/sachet daily Route of Administration: Oral administration with a glassful (approx. 250 mL) of water. |
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| CALCOL (Chicken Collagen Peptide) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Veg Collagen Peptide | Dietary Supplement | Mode of Usage: 1 scoop/sachet daily Route of Administration: Oral administration with a glassful (approx. 250 mL) of water |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in the facial wrinkles and fine lines of Crow's feet area, skin texture - roughness, dryness, wrinkles, smoothness | To evaluate the effectiveness of the test treatments for change in the facial wrinkles and fine lines of Crow's feet area, skin texture - roughness, dryness, wrinkles, smoothness using Visioscan® VC 20 Plus after 8 weeks of treatment, between treatments, between three different dosages and within a treatment | Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days) |
| Change in Skin Elasticity | To evaluate the effectiveness of the test treatments in skin elasticity using DermaLab®Combo or equivalent (Right cheek) after 8 weeks of treatment, between treatments, between three different dosages, and within a treatment | Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days) |
| Change in Skin Hydration | To evaluate the effectiveness of the test treatments in skin hydration using MoitureMeterEPiD (Right cheek) after 8 weeks of treatment, between treatments, between three different dosages, and within a treatment | Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days) |
| Change in Hair Thickness and Density | To evaluate the effectiveness of the test treatments for change in Hair Thickness and Density in using CASLiteNova through Phototrichogram after 8 weeks of treatment, between treatments, between three different dosages, and within a treatment | Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days) |
| Change in Hair Fall | To evaluate the effectiveness of the test treatments for change in hair fall using a 60-second hair count (Hair Combing Method) after 8 weeks of treatment, between treatments, between three different dosages, and within a treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Physician Global Assessment (PGA) scoring - Skin dryness, redness, fine wrinkling/lines, coarse wrinkling/lines, laxity, roughness and sallowness | To evaluate the effectiveness of the test treatments for change in Physician Global Assessment (PGA) scoring using the Griffiths scale - Skin dryness, redness, fine wrinkling/lines, coarse wrinkling/lines, laxity, roughness and sallowness after 8 weeks of treatment, between treatments, between three different dosages and within the treatment evaluated by dermatologist trained scorer |
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Inclusion Criteria:
The subject must fulfil all of the following inclusion criteria to be eligible for participation in the study unless otherwise specified.
Exclusion Criteria:
Subjects must not be enrolled in the study if they meet any one of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Nayan K Patel, MBBS | Medical Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NovoBliss Research Pvt Ltd | Gandhinagar | Gujarat | India |
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Proof of Science, Randomized, Four-arm, Comparative, Single-Blind, Evaluator-Blinded, Dose Response, Safety and Efficacy Study
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Subjects will be randomly assigned in as 1:1:1:1 ratio to receive either treatment A or B or C or D and three different dosages i.e. 2.5g, 5g, and 10g. The randomization code will be generated by NovoBliss Research. Single-blind will be followed for the evaluators.
Subjects will be randomly allocated to one of the treatment groups and one of treatment dose, as per the randomization code. This is single-blind study and blinding will be kept wherein neither the evaluator staff nor the Investigator shall be aware of the test treatment or test treatment dose allocation (except for osteoarthritis patients for Bovine Test Treatment). To maintain blinding, the study staff who involves in treatment dispensing and distribution will not be involved in any other study-related activities.
Chicken collagen is used to treat joint pain associated with many types of arthritis and surgery, as well as back pain, neck pain, and pain following injury. Chicken collagen works by causing participants' body to produce substances that fight inflammation and pain. It also contains chondroitin and glucosamine, two compounds that help rebuild cartilage. That's why chicken collagen can provide some amazing benefits for participants' gut, immune system, skin, and more.
Mode of Usage: 1 scoop/sachet daily Route of Administration: Oral administration with a glassful (approx. 250 mL) of water.
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| Bovine Collagen Peptide | Dietary Supplement | Mode of Usage: 1 scoop/sachet daily Route of Administration: Oral administration with a glassful (approx. 250 mL) of water |
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| Fish | Marine Collagen Peptide | Dietary Supplement | Mode of Usage: 1 scoop/sachet daily Route of Administration: Oral administration with a glassful (approx. 250 mL) of water |
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| Chicken Collagen Peptide | Dietary Supplement | Mode of Usage: 1 scoop/sachet daily Route of Administration: Oral administration with a glassful (approx. 250 mL) of water |
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| Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days) |
| Change in Body Weight and BMI | To evaluate the effectiveness of the test treatments for change in body weight in Kg and Body Mass Index (BMI) Kg/m2 after 8 weeks of treatment, between treatments, between three different dosages, and within a treatment | Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days) |
| Change in Joints Pain using VAS (0-10 cm) scoring evaluated by trained study staff | To evaluate the effectiveness of the test treatments for change in Joints Pain using VAS (0-10 cm) scoring evaluated by trained study staff after 8 weeks of treatment, between treatments, between three different dosages, and within a treatment | Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days) |
| Change in muscles strength | To evaluate the effectiveness of the test treatments for change in muscle strength as assessed by the sum of the handgrip, elbow flexion, and extension, and knee flexion and extension strength evaluated by trained study staff after 8 weeks of treatment, between treatments, between three different dosages, and within a treatment | Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days) |
| To assess the effect of test treatment in terms of change in hair growth on the scalp | Hair growth rate (µm/day) will be measured by using data of hair growth from Visit 01 and Visit 02 for baseline reading and from Visit 05 and Visit 06 for post-treatment reading. Note: Hair growth rate (μm/day) will be measured by using data of hair growth from Visit 01 and Visit 02 for baseline reading and from Visit 05 and Visit 06 for post-treatment reading | Baseline visit i.e. during Visit 01 (04 days before Day 01) and Visit 02 (Day01) before application to Visit 05 (Day 57) and Visit 06 (Day 60) |
| Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days) |
| Change in Glogau Skin Age | To evaluate the effectiveness of the test treatments for change in Glogau Skin Age after 8 weeks of treatment, between treatments, between three different dosages and within the treatment evaluated by a dermatologist trained scorer | Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days) |
| Change on hair strength by Pull test | To evaluate the effectiveness of the test treatments for change in scalp hair strength using the pull test method evaluated by dermatologist-trained scorer after 8 weeks of treatment, between treatments, between three different dosages, and within the treatment | Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days) |
| Change in Physician Global Assessment (PGA) score for assessment of the signs of brittle nails, surface roughness, raggedness, and peeling | To evaluate the effectiveness of the test treatments for change in Physician Global Assessment (PGA) score for assessment of the signs of brittle nails, surface roughness, raggedness, and peeling evaluated by dermatologist-trained scorer after 8 weeks of treatment, between treatments, between three different dosages, and within the treatment | Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days) |
| Change in Sleep Quality using Leeds Sleep Evaluation Questionnaires (LSEQ) | To evaluate the effectiveness of the test treatments for change in Sleep Quality using Leeds Sleep Evaluation Questionnaires (LSEQ) evaluated by trained staff after 8 weeks of treatment, between treatments, between three different dosages, and within the treatment | Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days) |
| Consumption of Rescue Medications for Joints pain | To evaluate the effectiveness of the test treatments for the requirement of consumption of rescue medications for Joints pain during and after 8 weeks of treatment, between treatments, between three different dosages, and within the treatment | Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days) |
| Test treatment perception and consumer feedback on Skin elasticity, suppleness, deep and sound sleep, digestion and gut health, joint health, and nail and hair health | To evaluate the effectiveness of the test treatments perception and consumer feedback on skin elasticity, suppleness, deep and sound sleep, digestion and gut health, joint health, and nail and hair health using hedonic questionnaires evaluated by trained study staff after 8 weeks of treatment, between treatments, between three different dosages, and within the treatment | Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days) |
| Change in Physician Global Assessment (PGA) score for assessment of Acne Severity | To evaluate the effectiveness of the test treatments for change in PGA score of acne severity evaluated by dermatologist trained scorer in enrolled subjects with mild to moderate acne - between treatments, between three different dosages, and within the treatment | Baseline (Day01) to Day 60 (+2Days) |
| Change in Anagen Telogen (A:T) ratio | To evaluate the effectiveness of the test treatments after 8 weeks of treatment in Anagen Telogen (A:T) ratio using pluck test - between treatments, between three different dosages and within treatment evaluated by dermatologist trained scorer to assess Hair growth cycle (Trichogram) | Baseline (Day01) to Day 60 (+2Days) |
| Change in facial photographs (left/center/right) and nails photographs of the subjects | Change in facial photographs (left/center/right) and nails photographs of the subjects in three different dosages and between treatments will be presented at the end of the study | Baseline (Day01) to Day 60 (+2Days) |
| ID | Term |
|---|---|
| D020345 | Enterocolitis, Necrotizing |
| C562907 | Twenty-Nail Dystrophy |
| D020370 | Osteoarthritis, Knee |
| D000152 | Acne Vulgaris |
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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