| CTRI Number |
CTRI/2022/05/042916 [Registered on: 30/05/2022] Trial Registered Prospectively |
| Last Modified On: |
15/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Turmeric-Boswellia Formulation in Menstrual Cramp Pain |
Scientific Title of Study
Modification(s)
|
A Double-Blind, Randomized, placebo-controlled Study to Assess the Efficacy of Turmeric-Boswellia Formulation in Menstrual Cramp Pain Associated with Primary Dysmenorrhea |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AN-05PFK0422H4-WES09, Version 1.0 dated 19 April 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Binu T Kuruvilla |
| Designation |
Chief Innovation Officer |
| Affiliation |
Arjuna Natural Private Limited |
| Address |
Division of Research and Development, Clinical Trial Department,
No.7/8, Bank Road, Aluva
Ernakulam
KERALA
683101
India |
| Phone |
09447818432 |
| Fax |
04842622612 |
| Email |
drbinu@arjunanatural.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Binu T Kuruvilla |
| Designation |
Chief Innovation Officer |
| Affiliation |
Arjuna Natural Private Limited |
| Address |
Division of Research and Development, Clinical Trial Department,
No.7/8, Bank Road, Aluva
Ernakulam
KERALA
683101
India |
| Phone |
09447818432 |
| Fax |
04842622612 |
| Email |
drbinu@arjunanatural.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Giby Abraham |
| Designation |
Research Associate |
| Affiliation |
Arjuna Natural Private Limited |
| Address |
Bank Road, Aluva
Ernakulam
KERALA
683101
India |
| Phone |
09288004381 |
| Fax |
|
| Email |
giby.a@arjunanatural.com |
|
|
Source of Monetary or Material Support
|
| Arjuna Natural Private Limited, Aluva, Kerala |
|
|
Primary Sponsor
|
| Name |
Arjuna Natural Private Limited |
| Address |
Bank Road, Aluva, Kerala, India - 683 101 |
| Type of Sponsor |
Other [Neutraceutical company] |
|
|
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 Divya Agarwal |
Mewa Chaudhary Hospital |
OPD- Room No. 15
Opp. MLB Medical college, Gate no. 2, Jhansi (U.P) 284128
Jhansi
UTTAR PRADESH |
08004911890
drdivya.nirmal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nirmal Hospital Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Primary dysmenorrhea |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
2 soft gel capsules of 500 mg as single dose, orally, one day |
| Intervention |
Turmeric-Boswellia formulation |
2 soft gel capsules of 500 mg as single dose, orally, one day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Healthy female participants between 18 and 35 years of age.
2. Participant has a history of regular menstrual cycles that typically occurs between every 21 to 35 days.
3. Participant has a self-reported history of primary dysmenorrhea with at least moderate menstrual cramp pain (based on the categorical pain intensity scale 0-3).
4. Participant is willing to participate in the study and give voluntary informed consent. |
|
| ExclusionCriteria |
| Details |
1. Participant has a known allergy to any of the ingredients in any of the study medication products;
2. Participant has significant co-existing illness, including gastrointestinal, hepatic, renal, neurologic, cardiovascular, psychiatric, endocrine, respiratory, surgical procedure or other condition that, in the Investigator’s judgment, contraindicates administration of the study medication;
3. Participant has a current or past history of one or more of the following conditions: secondary dysmenorrhea, pelvic inflammatory disease, urinary tract infection (currently acute or recurrent [defined as more than three per year]), adnexal masses, uterine fibroids, endometriosis, adenomyosis that in the opinion of the Investigator would impact participant safety and/or the study data;
4. Participant has an ongoing sexually transmitted disease (except for a history of genital herpes or Human Papillomavirus) or has abnormal vaginal discharge;
5. Participant requires prescription analgesics, narcotic, non-NSAID (i.e., defined as oral use of 5 or more times per week for greater than 3 weeks) or has routinely taken OTC medications in excess of label recommended instructions for control of dysmenorrhea symptoms;
6. Participant is taking mood-altering agents (e.g., antidepressants, sedatives, phenothiazines, or anti-anxiety agents).
7. Participant does not agree to abstain from taking any analgesic and/or anti- inflammatory approximately 72 hours prior to the anticipated treatment period and throughout the dosing/assessment period. All pain and anti-inflammatory medications including supplements, topical heat or cold, and other products of topical application will be discontinued approximately 72 hours prior to the anticipated dosing for treatment period and throughout the dosing/assessment period;
8. Participant is pregnant, lactating, or less than 6 months postpartum;
9. Participant is currently using an oral contraceptive for less than 3 months, has been on an unstable dose within the last 3 months or has switched from one oral contraceptive to another within the last 3 months of the study;
10. Participant has a history of alcohol intake daily or drug abuse.
11. Participant with a medical disorder, condition or history such that could impair the participant’s ability to participate or complete this study in the opinion of the investigator.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total Pain Relief scores (TOTPAR 6) using pain relief categorical scale (0-4). |
Each 30 min post-dose censored at 6 h |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Summed Pain Intensity Difference (SPID) over the 6-hour study period (SPID 0-6) using 0-10 NRS
•Pain Intensity Difference (PID) scores at each evaluation |
Each 30 min post-dose censored at 6 h |
| •Global Evaluation |
At 6 hours post-dose or immediately before first intake of rescue medication |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/05/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomized, double-blind, placebo-controlled
study in adolescent and adult female participants with primary dysmenorrhea of
at least moderate pain. Qualified participants will be randomized into two groups
in 1:1 ratio to a single dose of test product or placebo (two soft gel of 500
mg). The participant takes the assigned study
medication when menstrual cramp pain is ≥5 in severity using the 0-10 Numerical
Rating Scale (NRS) questionnaire. Before dosing, the participants will complete a
baseline (immediately before dosing) 0-10 NRS menstrual cramp pain intensity
evaluation. After taking the study medication, the participant will complete
the pain/pain relief assessment (0-10 NRS and the 0-4 categorical pain relief
scale) at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5-, 5.5- and 6-hours post-dose (30
minutes time intervals).
At 6 hours post-dose, the participant will complete the Global Evaluation of
her overall satisfaction with the effectiveness of the study medication. If the
participant decides to take rescue medication prior to the 6 hours, the
participant will be instructed to complete the Global Evaluation prior to
taking the rescue medication. |