Clinical trial of AHPL/AYLIQ/0717 Syrup in menstrual irregularities.

Phase 2/3

Completed

• Conditions: Irregular menstruation, unspecified. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH,

• Registration Number: CTRI/2022/09/045828
• Lead Sponsor: Ari Healthcare Pvt Ltd

Brief Summary

It is a randomized,comparative, double blind, multi-centric prospective, interventional clinicalstudy to evaluate efficacy and safety of AHPL/AYLIQ/0717 syrup in comparisonwith Marketed formulation in participants suffering from menstrualirregularities. Study will be conducted at 4 to 5 centers in India. Subjects willbe randomly assigned to AHPL/AYLIQ/0717 syrup group or marketed formulationsyrup group in 1: 1 ratio. Subjects will be asked to take given medication in adose of 3 teaspoons full twice daily orally after meals with water for 120 days.The primary objective of the study will be to assess number of subjectsachieving regular frequency of menstrual cycle. Secondary objectives of thestudy will be to assess number of subjects achieving regular menstrual bleeding days, changes inamount of menstrual bleeding, abdominal pain (spasm) on VAS, changesin symptoms associated with irregular menstruation, frequency of use of NSAIDsand / or antispasmodic drugs as rescue medications, global assessment foroverall change by physician and by patient, global assessment of tolerabilityof study drugs and changes in safety laboratory parameters on Day 0, Day 30,Day 60, Day 90 and Day 120.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-27
• Last Update Posted: 2023-12-25

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 86

Inclusion Criteria

• 1. Female patients diagnosed with irregular with non-organic causes for last 3 months.
• 2. Females willing to provide written informed consent and ready to comply with study protocol.

Exclusion Criteria

• 1. Subjects having organic causes of menstrual abnormalities like uterine myeloma, pelvic inflammatory disease adenomyosis, polyps, fibroids, endometriosis, cervical erosion and PCOS (as diagnosed by USG).
• 2. Subjects having clinical signs of hyper-andronism.
• 3. Subjects having known systematic illness like uncontrolled hypertension, uncontrolled diabetes mellitus, renal disease, tuberculosis, liver disorder, coagulation disorder, hypothyroidism, hyperthyroidism, hirsutism, Addison disease and or Cushing disease.
• 4. Subjects with known HIV, cancer, hepatitis B and C conditions.
• 5. Subjects with one year of history of delivery or abortion.
• 6. History of genitor-urinary surgery, and or other major medical or surgical diseases; which can affect or related with study outcomes.
• 7. Pregnant and lactating women.
• 8. Women of child bearing age, not willing to follow adequate contraceptive methods excluding oral contraceptive pills.
• 9. Use of corticosteroids or hormones or hormonal drugs within last 1 month from screening visit.
• 10. Use of any other investigational drug within 1 month prior to screening visit.
• 11. Subject who are not willing to refrain from the use of any Ayurvedic, Homeopathy, Unani, Siddha medicine, and Nutraceutical and food supplements for menstrual irregularity during trial duration.
• 12. Known hypersensitivity to ingredients used in study drugs.
• 13. Other conditions, which in the opinion of investigators, make patient unsuitable for enrolment or could interfere with her participation in, and completion of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of subjects achieving regular frequency of menstrual cycle	Day 0, Day 30, Day 60, Day 90 and Day 120.

Secondary Outcome Measures

Name	Time	Method
1) Number of subjects achieving regular menstrual bleeding days	2) Changes in amount of menstrual bleeding

Trial Locations

Locations (4)

Ayurved Seva Sangh’s, Ayurved Mahavidyalaya & Rugnalaya; 🇮🇳 Nashik, MAHARASHTRA, India

DY Patil College of Ayurved and Research Centre, Pimpri, Pune; 🇮🇳 Pune, MAHARASHTRA, India

Khemdas Ayurveda Hospital, Parul Institute of Ayurved and Research; 🇮🇳 Vadodara, GUJARAT, India

Parul Institute of Ayurved, Parul University; 🇮🇳 Vadodara, GUJARAT, India

Ayurved Seva Sangh’s, Ayurved Mahavidyalaya & Rugnalaya

🇮🇳Nashik, MAHARASHTRA, India

Dr Kirti Kate

Principal investigator

9960394413

kate.kirti@gmail.com