| CTRI Number |
CTRI/2022/05/042652 [Registered on: 19/05/2022] Trial Registered Prospectively |
| Last Modified On: |
12/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
study to Evaluate Efficacy and Safety of GRACE HING Asafotedia 15mg capsules in managing abdominal pain with cramping. |
|
Scientific Title of Study
|
An Open labelled, Single arm, clinical study to Evaluate Efficacy and Safety of GRACE HING (Hing oil 15 mg)
HPMC Capsules in the Treatment of Abdominal Pain and Functional Dyspepsia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PHAR/NG//2022/08, Version Date: 01 dated 16 Apr 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gurudev S |
| Designation |
Principal Investigator |
| Affiliation |
Gurudev Clinic |
| Address |
C/o Gurudev Clinic, Bazaar Rd, Old Town, Yelahanka, Bangalore – 560064
Bangalore
KARNATAKA
560064
India |
| Phone |
09446105917 |
| Fax |
|
| Email |
drsgrdv1980@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Baburao Vikram |
| Designation |
Director |
| Affiliation |
Pharexcel Consulting Private Limited |
| Address |
PharexcelConsulting Clinical Research Dept. Clinical Operations Section Plot No.11. 10th Cross AYR layout, Shettihalli Bengaluru, Banglore KARNATAKA 560015, India.
Bangalore
KARNATAKA
560015
India |
| Phone |
09878551428 |
| Fax |
09878551428 |
| 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.
Bangalore
KARNATAKA
500039
Bangalore
KARNATAKA
500039
India |
| Phone |
|
| Fax |
|
| Email |
sunil@nutragrace.com |
|
|
Source of Monetary or Material Support
|
| Nutra Grace;B-11/7 and 11/8, IDA Uppal; Hyderabad- 500039, Telangana, INDIA |
|
|
Primary Sponsor
|
| Name |
NUTRA GRACE |
| Address |
NUTRA GRACE B-11/7 & 11/8, IDA Uppal; Hyderabad- 500039, Telangana, INDIA |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gurudev S |
Gurudev clinic |
C/o Gurudev Clinic, Bazaar Rd, Old Town, Yelahanka, Bangalore – 560064
Bangalore
KARNATAKA |
9446105917
drsgrdv1980@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pharexcel Independent Ethics Committee (PIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K30||Functional dyspepsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Grace Hing (Hing oil 15mg) HPMC Capsules |
Each HMPC Capsules contains: Hing Oil- 15 mg. Take 2 capsules per day along with the meal |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects of age group between 18-60 years are included in the study.
2. Subjects who are considered to healthy systemically without any
comorbidities and malignancy are included in the study.
3. Subjects fulfilling the Rome Diagnostic criteria are included in the study.
4. Subjects with abdominal pain irrespective of underlying diagnosis related
toGastro-Intestinal system are included in the study.
5. Subjects with complaints of frequent occurrences of abdominal pain due to
natureof the disease are included in the study.
6. Subjects who are willing to give informed consent without any hindrance
areincluded in the study.
|
|
| ExclusionCriteria |
| Details |
1. Subjects below 18 years and above 60 years of age are excluded from the study.
2. Subjects with complaints of abdominal spasms due to other systemic diagnosis apart from Gastro-Intestinal systems such as
renal calculi, gall bladder stones, etc, are excluded from the study.
3. Subjects who are not willing to give informed consent are excluded from the study.
4. Subjects with co morbidities such as; Type 2 Diabetes mellitus, hypothyroidism, Hypertension are excluded from the study.
5.Subjects who have been diagnosed of chronic diseases such as cardiovascular diseases, cancer, respiratory conditions, orthopaedic conditions
associated with early and late complications are excluded from the study
6. Subjects who are associated with long tern usage of analgesics & who has pasthistory of Gastro-intestinal surgery are excluded from
the study.
7. Subjects with gastro or duodenal ulcers and are also afflicted with dysphagia &odynophagia are excluded from the study.
8. Subjects with persistent GI bleeding and frequent vomiting are excluded from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome was a decrease in VAS for
pain intensity. |
day 0 and day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the Nepean Dyspepsia Index (NDI) |
Baseline , Day 1 to Day 30 |
To assess Gastrointestinal Symptom Rating
Scale(GSRS) |
Day 1 to Day 30 |
| To assess Global overall symptom scale |
Day 1 to Day 30 |
| To assess Adverse events |
Day 1 to Day 30 |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="15" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/05/2022 |
| Date of Study Completion (India) |
05/08/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Grace Hing oil capsules are 100% Vegan & natural supplement. Grace Hing oil capsules serves a perfect natural remedy for abdominal bloating and gas problems. It activates secretion of more digestive enzymes and promotes healthy digestion with no loss of nutrition. Hing or Asafoetida is rich in antioxidants and may provide multiple benefits, particularly for digestive health. Benefits of using Grace Hing Capsules Grace Hing oil capsules being rich in fiber aids digestion and gas problems. Grace Hing oil capsules may help lower blood pressure by relaxing blood vessels. Hing oil has anti-inflammatory and antioxidant properties. Provides Relief from Respiratory Problems Provides relief with uterine spasm and abdominal spasm. Suggested dosage: 2 Capsules a day or as directed by Health care practicioner. Direction: As a dietary supplement, Keep out of reach of children Each HMPC Capsules contains: Hing Oil- 15 mg Ingredients: Frankincense Oil, Coconut oil, Vitamin-E. Banding solution: HPMC, IPA, Chocolate Brown Colour and water. Storage: Below 25c in a cool, dry and dark place.
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