| CTRI Number |
CTRI/2024/07/070121 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
28/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study the effect of Turmeric-Boswellia combination in females with menstrual pain. |
|
Scientific Title of Study
|
A Double-Blind, Randomized, Placebo-controlled Study to Assess the Efficacy of Rhuleave-K in subjects with Primary Dysmenorrhea and its associated symptoms. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AN-10PFK0524H1-WES20, Version 1 dated 21 May 2024 |
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 |
Arjuna Innovation Centre, Clinical Trial Department, Door No. 187/D, Behind ISRO, Erumathala P.O.
Ernakulam
KERALA
683101
India |
| Phone |
09447818432 |
| Fax |
|
| 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 |
Arjuna Innovation Centre, Clinical Trial Department, Door No. 187/D, Behind ISRO, Erumathala P.O.
KERALA
683101
India |
| Phone |
09447818432 |
| Fax |
|
| Email |
drbinu@arjunanatural.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Giby Abraham |
| Designation |
Senior Scientist Clinical Research |
| Affiliation |
Arjuna Natural Private Limited |
| Address |
Arjuna Innovation Centre, Clinical Trial Department, Door No. 187/D, Behind ISRO, Erumathala P.O.
Ernakulam
KERALA
683101
India |
| Phone |
09995215790 |
| Fax |
|
| Email |
giby.a@arjunanatural.com |
|
|
Source of Monetary or Material Support
|
| Arjuna Natural Pvt. Ltd., Bank Road, Aluva, Kerala, India - 683 101 |
|
|
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 = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shruti Kotangale |
AIMS Hospital |
Room No. 007, Ground floor, OPD, Department of Obstretics,
P/72, Milap Nagar, MIDC road, Dombivli East-421203
Thane
MAHARASHTRA |
9970784766
shruti26kot@gmail.com |
| Dr Monica Shinde |
Shivam Hospital |
Room No. 3, Ground floor, OPD, Department of Obstretics,
Plot No. 57, C.R.W.CHS, Kalyan road, Near MIDC water tank, Dombivli East-421203
Thane
MAHARASHTRA |
8692011888
drmonicashinde11@gmail.com |
| Dr Seema Shanbhag |
Shree Ashirwad Hospital |
Room No. 303, Second floor, OPD, Department of Obstretics, C/3, Shree Complex, opp. Mahavir Nagar, Manpada road, Dombivli East-421201
Thane
MAHARASHTRA |
9820380206
seema.shanbhag15@gmail.com |
| Dr Divya Agarwal |
Smt. Meva Choudhary Memorial Hospital |
Room No. 106, Ground floor, OPD, Department of Obstretics, OPP. MLB Medical College, Gate No 1&2, Kanpur Road
Jhansi
UTTAR PRADESH |
8004911890
drdivya.nirmal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Altezza Institutional Ethics Committee |
Approved |
| Altezza Institutional Ethics Committee |
Approved |
| Altezza Institutional Ethics Committee |
Approved |
| Nirmal Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Primary Dysmenorrhoea |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo 500 mg |
One capsule daily in the morning for three months |
| Comparator Agent |
Placebo 500 mg |
One capsule twice daily during menstrual phase for three menstrual cycles. |
| Intervention |
Turmeric-Boswellia Formulation (Rhuleave-K) softgel capsule 500 mg |
One capsule daily in the morning for three months |
| Intervention |
Turmeric-Boswellia Formulation (Rhuleave-K) softgel capsule 500 mg |
One capsule twice daily during menstrual phase for three menstrual cycles. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Healthy female subjects 18 years or older
2. Subject has a history of regular menstrual cycles that typically occurs between every 28 ± 5 days with minimum 3 days of menstrual flow.
3. History of at least 4 consecutive painful periods in the past 6 month
4. WaLIDD score (Working ability, location, intensity, days of pain, dysmenorrhea score) above 5
5. Average menstrual pain score of 50 mm or above on VAS pain scale.
6. Willing for non-pregnant status during entire study period
7. Willing to provide the informed consent form
|
|
| ExclusionCriteria |
| Details |
1. Subject has a known allergy to any of the ingredients in any of the study medication products Subject 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
2. Subject has a current or 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 subject safety and/or the study data
3. Subject has an ongoing sexually transmitted disease (except for a history of genital herpes or Human Papillomavirus) or has abnormal vaginal discharge
4. Subject is taking mood-altering agents (e.g., antidepressants, sedatives, phenothiazines, or anti-anxiety agents).
5. Subject is pregnant, lactating, or less than 6 months postpartum
6. Subject 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
7. Subject has a history of alcohol intake daily or drug abuse.
8. 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
9. 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
10. Subject with a medical disorder, condition, or history such that could impair the subject’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 |
1. Menstrual Pain intensity using Visual Analogue Scale.
2. Duration of Menstrual pain (hours) using menstrual pain diary.
3. Severity of dysmenorrhoea using WaLIDD score (Working ability, location, intensity, days of pain, dysmenorrhea score) |
Baseline, Each menstrual periods with treatment till trial completion. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Associated menstrual symptoms measured using symptoms severity scale. |
Baseline, Each menstrual periods with treatment till trial completion. |
| Menstrual characteristics using the menstrual pain diary . |
Baseline, Each menstrual periods with treatment till trial completion. |
| Treatment emergent Adverse events (TEAE) evaluation, and hypersensitivity. |
Throughout the study duration |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
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 female participants with primary dysmenorrhea. Qualified participants based on inclusion and exclusion criteria will be randomized into four groups in 1:1:1:1 ratio. The participant takes the assigned study medication as per the study protocol. The proposed study aims to build on the evidence supporting Turmeric Boswellia formulation as a potential treatment for primary dysmenorrhea. By investigating different dosages and extended treatment durations, this study seeks to provide comprehensive data on the efficacy, safety, and optimal use of Turmeric Boswellia formulation, potentially offering a new and effective option for women suffering from this common and debilitating condition. |