Efficacy of CL25216 on Hormonal Balance and Menstrual Health in Women With Primary Dysmenorrhea. (PD)

The Effect of CL25216 on Hormonal Balance and Menstrual Health in Women With Primary Dysmenorrhea: A Randomized, Double-blind, Placebo Controlled Clinical Trial

This study is to evaluate the effects of CL25216 on hormonal balance and menstrual health in women with primary dysmenorrhea. Enrolled subjects will receive either CL25216 - 250 mg/day or placebo.

Study Overview

• Status: Not yet recruiting
• Conditions: Primary Dysmenorrhea; Menstural Cramps
• Intervention / Treatment: Dietary supplement: CL25216; Other: Placebo

Detailed Description

The purpose of this study is to evaluate the effect of CL25216 on hormonal balance and menstrual health in women with primary dysmenorrhea. A total of 80 female aged between 25-40 years will be included in the study. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per the computer-generated randomization list. The subjects will be assigned to either CL25216 - 250 mg or placebo arms at 1:1 ratio. The subjects will be instructed to take one capsule a day after breakfast for 84 days. Apart from primary and secondary outcomes, the study will also record the vital signs and adverse events to evaluate the herbal composition safety and tolerability. The safety assessment of the CL25216 will also include routine laboratory investigations on blood, urine and clinical chemistry at Screening visit and the final visit of the intervention.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Andhra Pradesh
    • Nellore, Andhra Pradesh, India
      • DEC Healthcare Hospital,
      • Contact: Dr. S Sailaja, MS; Phone Number: 0861-2320232

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy females aged between 25-40 years with a Body Mass Index (BMI) of approximately 25 to 29 kg/m2.
• Healthy women with primary dysmenorrhea Grade 2 (measured using Verbal Multi-dimensional scoring system (VMSS)) at least for 1 day in 50 % of menstrual cycles and maximum pain intensity score ≥4 on a 10 cm VAS for at least 3 menstrual cycles before participating in the study.
• Subjects with regular menstrual cycles that typically occur between every 21-35 days (menstrual period 3-7 days) in last 6 months.
• Subjects with normal pelvic TVS and breast mammogram.
• Subjects without any chronic diseases having symptoms such as burning, itching, abnormal vaginal discharge.
• Subjects willing to provide their age of menarche and regularity in menstrual cycle.
• Subjects without any clinical history of Gynaecological disorders or ovarian pathology, pelvic pathology like pelvic inflammatory disease, tumour and fibroma or without any history of pelvic surgery (screened using pelvic transvaginal sonography (TVS))
• Subjects with normal thyroid profile
• Subjects willing not to use any analgesics 24 hrs. prior screening and throughout the study.
• Females of childbearing potential who are sexually active must agree to use adequate non-hormonal contraception during the study.
• Normal vital signs, including electrocardiogram (ECG) and laboratory evaluations (including clinical chemistry, haematology, and complete urinalysis) within the reference range for the testing laboratory or the results are deemed not clinically significant for inclusion into this study by the investigator.
• Subject understands the study procedures and provides signed informed consent to participate in the study

Exclusion Criteria:

• Subjects with irregular menstrual cycle (shorter than 21 and longer than 35 days) affecting the treatment and efficacy judgment.
• Subjects with secondary dysmenorrhea (menstrual pain associated with conditions such as endometriosis, pelvic inflammatory disease, leiomyomas, Mullerian anomalies, and adenomyosis and interstitial cystitis).
• Subjects who are on related medications such as NSAIDs or hormonal contraceptive pills or intrauterine contraceptive devices in the past 3 months.
• History of cerebrovascular disease, thrombo-embolic disorders, heart attack, or angina at any time or thrombophlebitis within the last 5 years, on anti-coagulant or anti-platelet drugs daily for any conditions.
• Subjects with a high blood pressure (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg) and Fasting blood glucose level >125 mg/dl at screening.
• Subjects who had any hormonal therapy or any other herbal products in the past 3 months.
• Hypothyroidism, hyperthyroidism, hyperprolactinemia, Cushing's syndrome and congenital adrenal hyperplasia, following a special diet for the past 3 months, taking drugs affecting insulin sensitivity or lipid and hormonal profiles, including glucocorticoids, ovulation-stimulating drugs, anti-obesity, anti-diabetes, anti-hypertensive, anti-estrogenic, anti-androgenic during the last 3 months.
• Active gall bladder disease, gynaecological or breast surgery in the last 6 months.
• Subjects underwent hysterectomy or bilateral oophorectomy.
• History of breast, endometrial, other gynaecological cancer at any time or other cancer within the last 5 years.
• Smokers or tobacco users.
• Alcohol intake (>2 standard drinks per day), or recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) or psychiatric drug users.
• Pregnant and lactating mothers.
• History of hypersensitivity reactions attributed to investigational product (IP) or its components or related products.
• History of positive hepatitis screening including Hepatitis B surface antigen or Hepatitis C virus (HCV) antibodies or subjects with human immunodeficiency virus (HIV) and /or syphilis.
• History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
• Any condition that in opinion of the Investigator, does not justify the subjects' participation in the study.
• Subjects with a systemic disease including tuberculosis, leucosis, collagenosis, multiple sclerosis or other autoimmune diseases.
• Subject consumes significant amounts of soya products in the diet or any products containing red clover, black cohosh, omega 3 or omega 6 fatty acids or any other Ayush or homeopathic preparations that can interfere with the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CL25216; CL25216: 250mg, One capsule a day after breakfast for 84 days.	Dietary supplement: CL25216; CL25216: 250mg, One capsule a day after breakfast for 84 days.
Other: Placebo; One capsule a day after breakfast for 84 days.	Other: Placebo; One capsule a day after breakfast for 84 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Menstrual symptom Questionnaire	The MSQ is a validated instrument designed to provide a concise assessment of menstrual pain symptoms. It consists of 25 items, each measuring the severity of climacteric symptoms on a scale from 1 (never) to 5 (always), in between 2 emans rarely, 3 means sometimes and 4 represents. The total score ranges from 29 to 125, with higher scores reflecting more severe menstrual pain symptoms.	At day 1, 28, 56, and 84

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain duration	No. of days subject experiencing the pain during menstrual cycle will be captured. As the no. of days increasing, QoL decreases.	At day 1, 28, 56, and 84
Female sexual function index	The FSFI was developed as a brief, easy-to-administer, self-report tool for assessing key dimensions or domains of sexual function and quality of life in various populations of women. Female Sexual Function Index (FSFI), a widely used tool with six domains (Arousal, Desire, Orgasm, Lubrication, Satisfaction, and Pain). The total FSFI score ranges from minimum score of 2 and maximum score of 36. Greater Scores indicates better sexual function	At day 1, 28, 56, and 84
Resting Metabolic Rate (RMR)	RMR reflects the caloric expenditure necessary for life, without accounting for physical activity or digestion, measured by using metabolic analyzer. Increase in RMR is a sign of improved metabolism	At day 1, 28, 56, and 84
Bodyweight	The subject's body weight is measured using a digital weighing scale. An improvement is indicated when the body weight falls within the normal range based on the subject's demographic characteristics.	At day 1, 28, 56, and 84
BMI	Body mass index is a calculated measure by considering the weight and height of a subject. A change in BMI from overweight to normal range is a positive indicator of healthy lifestyle.	At day 1, 28, 56, and 84
Waist Circumference	Waist circumference is measured around the abdomen, just above the navel. This value is influenced by the subject's height and weight. A reduction in waist circumference indicates improvement in body weight, as well as decreased fat storage and deposition	At day 1, 28, 56, and 84
Hip Circumference	It represents the maximum circumference measured around the buttocks. This measurement is influenced by the subject's height and weight. A reduction in this value indicates improvements in body weight, as well as a decrease in fat storage and deposition	At day 1, 28, 56, and 84
Quality of life questionnaire (Short Form -36)	The 36-Item Short Form (SF-36) is a self-reported questionnaire used to assess overall health and quality of life. It consists of 8 domains, each scored on a scale from 0 to 100. Higher scores indicate a better quality of life and improved health status.	At day 1, 28, 56, and 84
Subjective self-assessments on hair quality	This is a subjective measurement of hair quality by considering the hair fall rate. The Highest Possible Score is 5.	At day 1, 28, 56, and 84
Skin wrinkle assessment	Visual assessment of skin wrinkles used to evaluate the appearance of skin aging and to determine the severity of wrinkles. This kind of assessment is typically done by a healthcare professional or dermatologist and involves examining the skin surface to identify and score wrinkles. Grade ranging from 0 to 9 where 0 represents no wrinkles and 9 represents deep wrinkles.	At day 1, 28, 56, and 84
Subject's self-assessment of skin Questionnaire	As the perception of the skin radiance is subjective, a self-assessment has been performed through a questionnaire. The scores range from 0 to 10, with higher scores indicating better skin quality in terms of complexion, smoothness, texture, elasticity, and hydration	At day 1, 28, 56, and 84
HOMA-IR	HOMA-IR is a simple and widely used method to estimate insulin resistance (IR) in perimenopause/menopause. HOMA-IR can be useful in assessing cardio metabolic risk	At day 1, 28, 56, and 84
Free testosterone	Testosterone in females is produced by the ovaries, adrenal gland, and peripheral conversion of precursors like DHEA/androstenedione in fat/skin cells. Decrease in testosterone level results in increased pain severity.	At day 1, 28, 56, and 84
Total testosterone	Testosterone in females is produced by the ovaries, adrenal gland, and peripheral conversion of precursors like DHEA/androstenedione in fat/skin cells. Decrease in testosterone level results in increased pain severity.	At day 1, 28, 56, and 84
Estradiol	Estradiol is the most potent and biologically active form of estrogen in humans produced majorly by ovaries, followed by adrenal. Fluctuations in this hormone impacts menstrual pain.	At day 1, 28, 56, and 84
LH	It is a hormone made by the pituitary gland that plays a key role in the reproductive system of females. Changes in LH levels cause ovulatory changes.	At day 1, 28, 56, and 84
FSH	It is a hormone produced by the pituitary gland and plays a crucial role in the reproductive systems of females. Changes in FSH results in disturbed menstrual health.	At day 1, 28, 56, and 84
LH:FSH	This marker is to evaluate the diagnosis of ovarian dysfunction. Increase in this value reflects the follicular arrest and anovulation.	At day 1, 28, 56, and 84
Anti-Mullerian hormone	AMH (Anti-Müllerian Hormone) is a marker of ovarian reserve, reflecting the number of remaining follicles in the ovaries. AMH testing could help to assess the menstrual quality of life.	At day 1, 28, 56, and 84
TNF-alpha	Tumor necrosis factor-alpha (TNF-alpha) is a potent, pro-inflammatory cytokine primarily produced by macrophages and monocytes, acting as a critical mediator of systemic inflammation. Increase in this concentration causes strong uterine contractions and pain.	At day 1, 28, 56, and 84
IL-6	Interleukin-6 (IL-6) is a key pro-inflammatory cytokine significantly elevated in the plasma and menstrual blood of women with primary dysmenorrhea. Increase in this concentration promotes uterine contractions and causes pain.	At day 1, 28, 56, and 84
GLP-1	Glucagon-like peptide-1 (GLP-1) is a crucial metabolic hormone released from intestinal L-cells upon food intake that regulates blood sugar and appetite. Increasing in GLP-1 aids in weight management and metabolism.	At day 1, 28, 56, and 84

Collaborators and Investigators

• Sponsor: ApexCPG LLC

Publications and helpful links

General Publications

• Proctor M, Farquhar C. Diagnosis and management of dysmenorrhoea. BMJ. 2006 May 13;332(7550):1134-8. doi: 10.1136/bmj.332.7550.1134. No abstract available.
• Ferries-Rowe E, Corey E, Archer JS. Primary Dysmenorrhea: Diagnosis and Therapy. Obstet Gynecol. 2020 Nov;136(5):1047-1058. doi: 10.1097/AOG.0000000000004096.
• Gebeyehu MB, Mekuria AB, Tefera YG, Andarge DA, Debay YB, Bejiga GS, Gebresillassie BM. Prevalence, Impact, and Management Practice of Dysmenorrhea among University of Gondar Students, Northwestern Ethiopia: A Cross-Sectional Study. Int J Reprod Med. 2017;2017:3208276. doi: 10.1155/2017/3208276. Epub 2017 May 14.
• Chuamoor K, Kaewmanee K, Tanmahasamut P. Dysmenorrhea among Siriraj nurses; prevalence, quality of life, and knowledge of management. J Med Assoc Thai. 2012 Aug;95(8):983-91.
• Chen CX, Shieh C, Draucker CB, Carpenter JS. Reasons women do not seek health care for dysmenorrhea. J Clin Nurs. 2018 Jan;27(1-2):e301-e308. doi: 10.1111/jocn.13946. Epub 2017 Sep 7.

Study record dates

Study Major Dates

• Study Start (Estimated): April 13, 2026
• Primary Completion (Estimated): September 10, 2026
• Study Completion (Estimated): September 10, 2026

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: APX/PD/CL25216/25; CTRI/2026/04/107776 (Registry Identifier: Clinical Trial Registry - India Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No