Type 1 DiabetesNCT06487598
To Evaluate add-on Effect of Nisha-Amalaki Tablets Along With Insulin on Glycemic Control in Type 1 Diabetes Patients (RCTNA)
A study testing inj insulin to one group and Inj Insulin with Tab Nisha-Amalaki 500 mg twice a day in people with Type 1 Diabetes, run by Hirabai Cowasji Jehangir Medical Research Institute at 1 site in India.
Trial summary
Type-I diabetes mellitus (T1DM) is an autoimmune condition, in which the pancreas reduces/stops insulin production. Patients with T DM have to take insulin injections with every meal and also usually a long-acting preparation. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- inj insulin to one group and Inj Insulin with Tab Nisha-Amalaki 500 mg twice a day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jul 2024to Jul 2025
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- K/C/O type-I DM for more than 1 year
- Age above 10 years, (10-18 years) irrespective of sex, religion, and economic status
- Parents provide consent and children providing assent for the study
Who cannot join
- K/C/O type-I DM for more than 1 year
- Age above 10 years, (10-18 years) irrespective of sex, religion, and economic status
- Parents provide consent and children providing assent for the study
Trial locations and contacts
1 site in 1 country.
India1 site
Hirabai Cowasji Jehangir Medical Research Institute
Pune, Maharashtra, 411001
About this study
Official title: Pilot Randomized Controlled Trial to Evaluate add-on Effect of Amalaki (Phyllantus Emblica) and Haridra (Curcuma Longa) Along With Insulin on Glycaemic Control in Patients With Type-I Diabetes Mellitus.
Type-I diabetes mellitus (T1DM) is an autoimmune condition, in which the pancreas reduces/stops insulin production. Patients with T DM have to take insulin injections with every meal and also usually a long-acting preparation. In India, approximately 8.6 lakh people suffer from T1DM, and one in six young patients dies without a diagnosis.
Significant advancements are being made in the field of T1DM research, including stem cell therapy, islet cell transplantation, and immunotherapies, which hold promise for the future. However, so far, there is no known permanent cure for T1DM. Thus, treatment of T1DM aims at maintaining normal blood sugar levels through regular monitoring, insulin therapy, diet, and exercise.
Read more
Dietary constituents play an important role in the management of T1DM. Studies have shown that the fruits of Phyllanthus emblica Linn, colloquially known as Indian gooseberry (amla), and/or some of its important constituents (including gallic acid, gallotanin, ellagic acid, and corilagin) possess anti-diabetic actions through their antioxidant and free-radical-scavenging properties. Amla has also been reported to prevent or reduce hyperglycemia, cardiac complications, diabetic nephropathy, neuropathy, cataract genesis, and protein wasting. However, clinical trial data with human subjects are limited and preliminary.
Numerous studies also report that turmeric (Curcuma longa) has antioxidant, anti-inflammatory, and anti-diabetic activities and can lower lipid levels. The hypoglycaemic effect of turmeric may be due to increased peripheral glucose utilization, decreased hepatic glucose synthesis, and/or increased insulin secretion.
In Ayurveda, the combination of turmeric (haridra) and amla (amalaki) is strongly recommended for Prameha (Diabetes mellitus).
- Conditions
- Type 1 Diabetes
- Being tested
- inj insulin to one group, Inj Insulin with Tab Nisha-Amalaki 500 mg twice a day
- Keywords
- Type-I diabetes mellitus, Haridra, Amalaki, Prameh
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inj insulin to one groupDrug
Also called Inj Insulin
One group- only inj insulin for 3 months.
Inj Insulin with Tab Nisha-Amalaki 500 mg twice a dayDrug
second group- Inj Insulin with Tab Nisha-Dhatri 500 mg twice a day
| Study group | Role | What they receive |
|---|---|---|
| Arm1-Only insulin treatment for type 1 Diabetes patients | Active comparator | Arm1:-Insulin treatment- 4 times a day (Basal Bolus insulin) Inj Actrapid from Novo-Nordisk company and Inj Lantus from Sanofi company given as per body weight of patient for 3 months. Receives: Drug: inj insulin to one group; Drug: Inj Insulin with Tab Nisha-Amalaki 500 mg twice a day |
| Arm2-Insulin with Nisha-Amalaki tablets | Active comparator | Arm2:-Insulin treatment- 4 times a day (Basal Bolus insulin) Inj Actrapid from Novo-Nordisk company and Inj Lantus from Sanofi company given as per body weight of patient with Tab Nisha-Amalaki Dhootpapeshwar GMP certified 500 mg twice a day for 3 months. Receives: Drug: inj insulin to one group; Drug: Inj Insulin with Tab Nisha-Amalaki 500 mg twice a day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control (HbA1c)
Change in glycemic control will be assessed using glycated hemoglobin (HbA1c) by standardized assays.
Measured: 3 months
Change in a insulin dose
Change in an insulin dose will be assessed at baseline and after 3 months of intervention by administering a standardised questionnaire.
Measured: 3 months
Secondary outcomes (4)
Change in urinary parameter.
Change in urinary parameter will be assessed by doing albumin:creatinine ratio(ug/mg)
Measured: 3 months
Change in blood parameter-lipid profile.
Chane in cholesterol(mg/dl), triglycerides(mg/dl),Low density Lipoprotein(mg/dl)
Measured: 3 months
Change in Fat (%)
Change in Body composition by using Bioelectrical Impedance Analysis(BIA)
Measured: 3 months
Change in Body composition.
Change in fat mass ( kg) by using Bioelectrical Impedance Analysis(BIA)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start1 Jul 2024
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hirabai Cowasji Jehangir Medical Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Anuradha Khadilkar, Hirabai Cowasji Jehangir Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487598
- Sponsor's protocol ID
- JCDC/BHR/24/032
- Status last verified
- Oct 2024
- First submitted
- 27 Jun 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Controlled Trial to Evaluate add-on Effect of Amalaki (Phyllantus Emblica) and Haridra (Curcuma Longa) Along With Insulin on Glycaemic Control in Patients With Type-I Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT06487598
- Acronym / sponsor ID
- JCDC/BHR/24/032
- Conditions
- Type 1 Diabetes
- Keywords
- Type-I diabetes mellitus, Haridra, Amalaki, Prameh
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hirabai Cowasji Jehangir Medical Research InstituteUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 5 Jul 2024 (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.
Type-I diabetes mellitus (T1DM) is an autoimmune condition, in which the pancreas reduces/stops insulin production. Patients with T DM have to take insulin injections with every meal and also usually a long-acting preparation. In India, approximately 8.6 lakh people suffer from T1DM, and one in six young patients dies without a diagnosis.
Significant advancements are being made in the field of T1DM research, including stem cell therapy, islet cell transplantation, and immunotherapies, which hold promise for the future. However, so far, there is no known permanent cure for T1DM. Thus, treatment of T1DM aims at maintaining normal blood sugar levels through regular monitoring, insulin therapy, diet, and exercise.
Dietary constituents play an important role in the management of T1DM. Studies have shown that the fruits of Phyllanthus emblica Linn, colloquially known as Indian gooseberry (amla), and/or some of its important constituents (including gallic acid, gallotanin, ellagic acid, and corilagin) possess anti-diabetic actions through their antioxidant and free-radical-scavenging properties. Amla has also been reported to prevent or reduce hyperglycemia, cardiac complications, diabetic nephropathy, neuropathy, cataract genesis, and protein wasting. However, clinical trial data with human subjects are limited and preliminary.
Numerous studies also report that turmeric (Curcuma longa) has antioxidant, anti-inflammatory, and anti-diabetic activities and can lower lipid levels. The hypoglycaemic effect of turmeric may be due to increased peripheral glucose utilization, decreased hepatic glucose synthesis, and/or increased insulin secretion.
In Ayurveda, the combination of turmeric (haridra) and amla (amalaki) is strongly recommended for Prameha (Diabetes mellitus).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm1-Only insulin treatment for type 1 Diabetes patients | Active comparator | Drug: inj insulin to one group, Drug: Inj Insulin with Tab Nisha-Amalaki 500 mg twice a dayArm1:-Insulin treatment- 4 times a day (Basal Bolus insulin) Inj Actrapid from Novo-Nordisk company and Inj Lantus from Sanofi company given as per body weight of patient for 3 months. |
| Arm2-Insulin with Nisha-Amalaki tablets | Active comparator | Drug: inj insulin to one group, Drug: Inj Insulin with Tab Nisha-Amalaki 500 mg twice a dayArm2:-Insulin treatment- 4 times a day (Basal Bolus insulin) Inj Actrapid from Novo-Nordisk company and Inj Lantus from Sanofi company given as per body weight of patient with Tab Nisha-Amalaki Dhootpapeshwar GMP certified 500 mg twice a day for 3 months. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- K/C/O type-I DM for more than 1 year
- Age above 10 years, (10-18 years) irrespective of sex, religion, and economic status
- Parents provide consent and children providing assent for the study
Key exclusion criteria (3 listed)
- K/C/O type-I DM for more than 1 year
- Age above 10 years, (10-18 years) irrespective of sex, religion, and economic status
- Parents provide consent and children providing assent for the study
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 |
|---|---|---|
| inj insulin to one groupAlso: Inj InsulinOne group- only inj insulin for 3 months. | Drug | Arm1-Only insulin treatment for type 1 Diabetes patients, Arm2-Insulin with Nisha-Amalaki tablets |
| Inj Insulin with Tab Nisha-Amalaki 500 mg twice a daysecond group- Inj Insulin with Tab Nisha-Dhatri 500 mg twice a day | Drug | Arm1-Only insulin treatment for type 1 Diabetes patients, Arm2-Insulin with Nisha-Amalaki tablets |
Primary outcome
Glycemic control (HbA1c)
Time frame: 3 months
Change in glycemic control will be assessed using glycated hemoglobin (HbA1c) by standardized assays.
Change in a insulin dose
Time frame: 3 months
Change in an insulin dose will be assessed at baseline and after 3 months of intervention by administering a standardised questionnaire.
4 secondary outcomes
Change in urinary parameter.
Time frame: 3 months
Change in blood parameter-lipid profile.
Time frame: 3 months
Change in Fat (%)
Time frame: 3 months
Change in Body composition.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inj insulin to one group and Inj Insulin with Tab Nisha-Amalaki 500 mg twice a day in people with Type 1 Diabetes, run by Hirabai Cowasji Jehangir Medical Research Institute at 1 site 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Results are not available in the source record.
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?
Glycemic control (HbA1c) (time frame: 3 months). The study lists 2 primary outcomes in all. 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 2 Oct 2024.