| CTRI Number |
CTRI/2021/04/032735 [Registered on: 12/04/2021] Trial Registered Prospectively |
| Last Modified On: |
20/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the effectiveness and safety of NEEMINT capsules in management of gastrointestinal disorders including Irritable bowel syndrome |
|
Scientific Title of Study
|
An open label single arm clinical trial to evaluate the safety and efficacy of NEEMINT capsules in management of gastrointestinal disorders including irritable bowel syndrome. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PHAR/2021/NG/04, Version 1.0 dated 13 March 2021 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Giriraja KV |
| Designation |
Principal Investigator |
| Affiliation |
Consultant- General Medicine |
| Address |
Department of General Medicine,
Rajalakshmi Hospital,
Lakshmipura Main Road, Vidyaranyapura Post,Bangalore-560097 Bangalore KARNATAKA
Bangalore KARNATAKA 560097 India |
| Phone |
|
| Fax |
|
| Email |
drgirirajkv@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Baburao Vikram |
| Designation |
Directortor |
| Affiliation |
Pharexcel Consulting |
| Address |
Pharexcel Consulting,
11, 10th Cross, AYR lay out,
Shettyhalli Jalahalli West,Bangalore.
Bangalore KARNATAKA 560015 India |
| Phone |
|
| Fax |
|
| Email |
info@pharexcelconsulting.com |
|
Details of Contact Person Public Query
|
| Name |
Mr Sunil Gupta |
| Designation |
Managing Director |
| Affiliation |
Nutra Grace |
| Address |
NUTRA GRACE; B-11/7 & 11/8, IDA Uppal; Hyderabad- 500039, Telangana, INDIA.
Hyderabad
TELANGANA
500039
Hyderabad TELANGANA 500039 India |
| Phone |
|
| Fax |
|
| Email |
sunil@nutragrace.com |
|
|
Source of Monetary or Material Support
|
| NUTRA GRACE; B-11/7 & 11/8, IDA Uppal; Hyderabad- 500039, Telangana, INDIA |
|
|
Primary Sponsor
|
| Name |
NUTRA GRACE |
| Address |
B-11/7 & 11/8, IDA Uppal; Hyderabad- 500039, Telangana, INDIA |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Giriraja KV |
Rajalakshmi Hospital & Research Center |
Dept. of General medicine, Ground floor, Room Number 1, 21/1, Lakshmipura Main Road, Vidyaranyapura Post Bangalore-560097 Bangalore KARNATAKA |
9448039952
drgirirajkv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajalakshmi Hospital Institutional Ethics Committee. |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K582||Mixed irritable bowel syndrome. Ayurveda Condition: GRAHANIDOSHAH, (2) ICD-10 Condition:K580||Irritable bowel syndrome with diarrhea. Ayurveda Condition: GRAHANIDOSHAH, (3) ICD-10 Condition:K581||Irritable bowel syndrome with constipation. Ayurveda Condition: GRAHANIDOSHAH, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Neemint capsules (Each enteric coated capsule contains Neem Oil 350 mg and Peppermint Oil 150 mg) |
Dose: 2 capsules to be taken on empty stomach each day.
Frequency: Once daily
Route of administration: Oral
Duration: 28 days |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects in the age group of 18-65 yrs (Inclusive of both genders).
2. Subjects with 2 or more symptoms like indigestion ,abdominal pain or cramps, nausea ,vomiting, bloating, constipation, diarrhoea, changes in bowel habits, loss of appetite.
3. Subjects/legal representative, willing to give a voluntary written informed consent.
4. Subjects should not participate in any other clinical study during participation in the current study
|
|
| ExclusionCriteria |
| Details |
1. Subjects with any cardiovascular, renal, respiratory or any other chronic illness.
2. Pregnant or lactating females.
3. Allergy to test product.
4. Any subject, in the investigators opinion not considered suitable for enrollment.
5. Subject participating in a similar clinical study, currently or during the previous 90 days |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Gastrointestinal Symptom Rating Scale [GSRS- IBS] |
Baseline, 1 week, 2 Weeks and 4 Weeks |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| IBS- Quality of life questionnaire |
Baseline, Day 7, Day 14 and Day 28 |
| Change in Subject’s Global Assessment of Symptoms |
Day 1 to Day 28 |
| Monitoring of AE and SAE |
Day 1 to Day 14 |
|
|
Target Sample Size
|
Total Sample Size="15" Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="15" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2021 |
| Date of Study Completion (India) |
26/04/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
05/06/2021 |
|
Estimated Duration of Trial
|
Years="0" Months="3" 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
|
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Brief Summary
|
Irritable bowel syndrome (IBS) is a common disorder that affects the large intestine. Signs and symptoms include cramping, abdominal pain, bloating, gas, and diarrhea or constipation, or both. IBS is a mix of belly discomfort or pain and trouble with bowel habits: either going more or less often than normal (diarrhea or constipation) or having a different kind of stool (thin, hard, or soft and liquid). There are four types of the condition: · IBS with constipation (IBS-C) · IBS with diarrhea (IBS-D) · Mixed IBS (IBS-M) alternates between constipation and diarrhea · Unsubtyped IBS (IBS-U) for people who don’t fit into the above types IBS isn’t life-threatening, and it doesn’t make you more likely to get other colon conditions, such as ulcerative colitis, Crohn’s disease, or colon cancer. Anti spasmodic, Anti diarrheal, proton pump inhibitors are a few of the remedies which one usually adopts, but it is however not natural and can cause side effects. NEEMINT capsule is a blended formulation of neem and peppermint oil, which both together can relieve symptoms of gastrointestinal disorders including Irritable bowel syndrome. Neem oil Neem oil extracted from the neem plant is said to be extremely beneficial for health. The extract from the neem bark has powerful properties to cure these ailments safely. This usually happens because Neem increases the quantity of gastric mucus which plays a major role in combating ulcers. Neem is considered a useful therapy for ulcers and gastric discomfort. Compounds in neem have been proven to have ant ulcerative effects. Peptic ulcers and duodenal ulcers are treated well with neem leaf extracts; nimbidin from seed extracts taken orally prevents duodenal lesions and peptic ulcers, and provides significant reductions in acid output and gastric fluid activity. Neem is also useful in treating other problems in the stomach and bowels. The herb promotes a healthy digestive system by protecting the stomach, aiding in elimination, and removing toxins and noxious bacteria. Its leaves are often used to treat heartburn and indigestion. Some neem extracts reduce the concentration of hydrochloric acid in the stomach. Neem extracts are also used to treat gastritis. The extracts reduce the amount of acid in the stomach; their antibacterial and anti-inflammatory properties can relieve the effects of this condition. Neem has also been shown to be effective for treating digestive disorders such as diarrhea, dysentery, hyperacidity and constipation. For diarrhoea and constipation also neem is found to be effective. Peppermint oil Peppermint oil is an aromatic herb extracted from peppermint plant. It is used to treat Irritable bowel syndrome and other digestive issues. Contraindications Peppermint oil is relatively contraindicated in patients with hiatal hernia or significant gastroesophageal reflux disease, because its effect on the lower esophageal sphincter can lead to exacerbation of symptoms. Peppermint oil has been used to trigger menstruation and should be avoided during pregnancy. Warnings and Precautions 1. Neemint capsules are likely unsafe when taken by mouth during pregnancy. They can cause a miscarriage. 2. Neem might lower blood sugar levels. There is a concern that it might interfere with blood sugar control during and after surgery. Stop using neem at least 2 weeks before a scheduled surgery. Side effects and adverse reactions 1. Peppermint can cause some side effects including heartburn, and allergic reactions including flushing, headache, and mouth sores. 2. When neem is taken by mouth in large doses or for long periods of time ,it might harm the kidneys and liver. Rationale for the study: · This study is proposed to evaluate the efficacy and safety of test product NEEMINT Capsules to prevent gastrointestinal disorders including irritable bowel syndrome. |