| CTRI Number |
CTRI/2022/05/042651 [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
|
A Study to evaluate the Efficacy and safety of Grace Hing Asafoetida 15mg Capsules in Primary
Dysmenorrhea.
|
|
Scientific Title of Study
|
An Open Labelled Single Arm Clinical Study To evaluate the Efficacy and safety of Grace Hing (Hing oil 15mg) HPMC Capsules in the Treatment of Primary Dysmenorrhea |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PHAR/NG//2022/07, Version 01 dated 16 Apr 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Urvashi Bhatara |
| Designation |
Principal Investigator |
| Affiliation |
NRR Hospital |
| Address |
Gyneocology Department , room number 2, Ground Floor, Janapriya Apartments 3&3A, Hesarghatta Main Rd, Next to, Geleyara Balaga Layout, Jalahalli West, Bengaluru, Karnataka 560090
Bangalore
KARNATAKA
560090
India |
| Phone |
09448696741 |
| Fax |
|
| Email |
urvashibhatara@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Baburao Vikram |
| Designation |
Director |
| Affiliation |
Pharexcel Consulting Private Limited |
| Address |
Clinical Research Dept, Ground floor, room number 1, 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 GRACED B-11/7 & 11/8, IDA Uppal; Hyderabad- 500039, Telangana, INDIA
Bangalore
KARNATAKA
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 |
|
|
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 Urvashi Bhatara |
NRR Hospital |
Gyneocology Department , room number 2, Janapriya Apartments 3&3A, Hesarghatta Main Rd, Next to, Geleyara Balaga Layout, Jalahalli West, Bengaluru, Karnataka 560090
Bangalore
KARNATAKA |
09448696741
urvashibhatara@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| 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: N944||Primary dysmenorrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Grace Hing (Hing oil 15mg) HPMC Capsules |
Each HMPC Capsules contains:
Hing Oil- 15 mg. Take
liquid filled vegetarian capsule
twice daily, along with the meal |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Healthy female patients between 18 – 35 years of age.
2. Patient has a history of Over-the-Counter (OTC) analgesic use for treatment of primary dysmenorrhea;
3. Patient has a history of regular menstrual cycles that typically occurs between every 21 to 35 days
4. Patients having a self-reported history of primary dysmenorrhea with other causes of dysmenorrhea having been excluded.
5. Patient who normally experiences pain relief from the analgesic medications in taken.
|
|
| ExclusionCriteria |
| Details |
1. Patient has a known allergy to any of the excipients in any of the study medication products.
2. GI Disorders hepatic, renal, neurologic, cardiovascular, psychiatric, endocrine, respiratory, surgical procedure.
3.Patient has an ongoing sexually transmitted disease or has abnormal vaginal discharge.
4. Patient has a current or past history of severe gastritis, gastrointestinal bleeding or ulceration.
5. Patient has a current or past history of one or more of the following conditions: secondary dysmenorrhea, pelvic inflammatory disease, urinary tract infection, adnexal masses, uterine fibroids, endometriosis, adenomyosis that in the opinion of the Investigator would impact patient safety and/or the study data.
6. patient requires prescription Analgesics, narcotic, non-NSAID or has routinely taken OTC medications in excess of label recommended instructions for control of dysmenorrhea symptoms.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The difference between the reported Visual
Analogue Scale before and after the
treatment(Grace hing capsule-15mg). Each
participant will rank the severity of her
dysmenorrhea symptoms before and after the
treatment use on the VAS scale from 0 to 100,
where 0 determines- "No pain" and 100
determines "Very painful". Then, the difference
between the two measurements will be
calculated |
3 days before the beginning of the menstrual
period and up to three days after termination of
the menstrual period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the improvement in the quality of life
determined by SF- 36 health survey
questionnaire |
3 days before the beginning of the menstrual
period and up to three days after termination of
the menstrual period |
To assess the associated systemic symptoms
Score of Dysmenorrhea |
3 days before the beginning of the menstrual
period and up to three days after termination of
the menstrual period |
To assess the PBLAC score for menstrual blood
loss. |
During the Menstural Period for 5 days |
|
|
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) |
24/08/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
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 as 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 1. Grace Hing oil capsules being rich in fiber aids digestion and gas problems. 2. Grace Hing oil capsules may help lower blood pressure by relaxing blood vessels. 3. Hing oil has anti-inflammatory and antioxidant properties. 4. Provides Relief from Respiratory Problems 5. Provides relief with uterine spasm and abdominal spasm
Suggested dosage: 2 Capsules a day or as directed by Health care practioner.
Direction: As a dietary supplement, Keep out of reach of childrean
Each HMPC Capsules contains: Hing Oil- 15 mg Ingredients: other 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. |