Diabetic NeuropathiesNCT04504305
To Assess the Efficacy of Investigational Product on the Neuropathic Pain in Individuals Suffering From Type II Diabetes Mellitus.
A study testing NeuropAWAY and Microcystalline cellulose in people with Diabetic Neuropathies and Insomnia Due to Medical Condition, run by Vedic Lifesciences Pvt. Ltd. at 2 sites in India.
Trial summary
this study is to be carried out to examine the effect of Investigation product on diabetic individuals suffering from diabetic neuropathic pain. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Diabetic Neuropathies, Insomnia Due to Medical Condition
- What is being tested?
- NeuropAWAY and Microcystalline cellulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 2 sitesIndia
- Study dates
- 23 Jul 2020to 18 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and Females aged ≥ 40 and ≤ 65 years of age.
- Participants with primary complaints of lower limb pain.
- History of Diabetes mellitus for more than one year.
- Participants with HbA1c ≥ 7.1 and ≤ 9.5%
Who cannot join
- Diagnosed with severe cardiac disease
- Uncontrolled hypertension defined as systolic blood pressure ≥ 139 and diastolic blood pressure ≥ 85.
- Type II DM with history of foot ulcers in the last six months prior to the study
- History of nerve damage not due to Painful Diabetic Neuropathy.
Trial locations and contacts
2 sites in 1 country.
India2 sites
Stress Test Clinic
Mumbai, Maharashtra, 400047
Shantaee
Mumbai, Maharashtra, 400067
About this study
Official title: A Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy of Investigational Product Nerve Support Formula on the Neuropathic Pain in Individuals Suffering From Type II Diabetes Mellitus.
this study is to be carried out to examine the effect of Investigation product on diabetic individuals suffering from diabetic neuropathic pain.
- Being tested
- NeuropAWAY, Microcystalline cellulose
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuropAWAYOther
2 capsules thrice daily to be taken half an hour prior to meal.
Microcystalline celluloseOther
2 capsules thrice daily to be taken half an hour prior to meal.
| Study group | Role | What they receive |
|---|---|---|
| Neuropaway | Active comparator | Not described Receives: Other: NeuropAWAY |
| Microcystalline cellulose | Placebo comparator | Not described Receives: Other: Microcystalline cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by 11 point numeric rating scale.
pain intensity will be assessed by 11 point numeric rating scale where 0 indicates no pain and 10 indicates worst possible pain
Measured: 42 days
Secondary outcomes (3)
effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by Brief pain inventory.
Measured: 42 days
effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by insomnia Severity index.
Measured: 42 Days
effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by Neuropathy total symptom score - 6 .
Measured: 42 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start23 Jul 2020
- Primary completion7 Jan 2021
- Study completion18 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504305
- Sponsor's protocol ID
- VC/190403/NUEROPAWAY/PN
- Status last verified
- Aug 2020
- First submitted
- 4 Aug 2020
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy of Investigational Product Nerve Support Formula on the Neuropathic Pain in Individuals Suffering From Type II Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT04504305
- Acronym / sponsor ID
- VC/190403/NUEROPAWAY/PN
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Jul 2020 (actual)
- Primary completion
- 7 Jan 2021 (actual)
- Study completion
- 18 Feb 2021 (actual)
- First posted
- 7 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
this study is to be carried out to examine the effect of Investigation product on diabetic individuals suffering from diabetic neuropathic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuropaway | Active comparator | Other: NeuropAWAY |
| Microcystalline cellulose | Placebo comparator | Other: Microcystalline cellulose |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and Females aged ≥ 40 and ≤ 65 years of age.
- Participants with primary complaints of lower limb pain.
- History of Diabetes mellitus for more than one year.
- Participants with HbA1c ≥ 7.1 and ≤ 9.5%
Key exclusion criteria (4 listed)
- Diagnosed with severe cardiac disease
- Uncontrolled hypertension defined as systolic blood pressure ≥ 139 and diastolic blood pressure ≥ 85.
- Type II DM with history of foot ulcers in the last six months prior to the study
- History of nerve damage not due to Painful Diabetic Neuropathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuropAWAY2 capsules thrice daily to be taken half an hour prior to meal. | Other | Neuropaway |
| Microcystalline cellulose2 capsules thrice daily to be taken half an hour prior to meal. | Other | Microcystalline cellulose |
Primary outcome
effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by 11 point numeric rating scale.
Time frame: 42 days
pain intensity will be assessed by 11 point numeric rating scale where 0 indicates no pain and 10 indicates worst possible pain
3 secondary outcomes
effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by Brief pain inventory.
Time frame: 42 days
effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by insomnia Severity index.
Time frame: 42 Days
effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by Neuropathy total symptom score - 6 .
Time frame: 42 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
Related trials for Diabetic Neuropathies
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Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Recruiting
Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
Diabetic Neuropathies, Diabetes Mellitus (Type 2)
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Active, not recruiting
Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuropAWAY and Microcystalline cellulose in people with Diabetic Neuropathies and Insomnia Due to Medical Condition, run by Vedic Lifesciences Pvt. Ltd. at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by 11 point numeric rating scale. (time frame: 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.