CTRI/2022/09/045828 [Registered on: 23/09/2022] Trial Registered Prospectively
Last Modified On:
25/12/2023
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Ayurveda
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Clinical trial of AHPL/AYLIQ/0717 Syrup in menstrual irregularities.
Scientific Title of Study
A randomized, comparative, double blind, multi-centric, prospective, interventional clinical study to evaluate efficacy and safety of ‘AHPL/AYLIQ/0717 syrup’ in comparison with Marketed formulation in participants suffering from menstrual irregularities.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
AHPL/AYLIQ/0717/2022/CT-1, Version No: V1 (06.07.2022)
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Jayashree Rajendra Patil
Designation
Professor & HOD, Department of Stri-Roga and Prasuti Tantra
Affiliation
DY Patil College of Ayurved and Research Centre
Address
Department of Stri-Roga and Prasuti Tantra,
DY Patil College of Ayurved and Research Centre, Pimpri, Pune
Pune MAHARASHTRA 411018 India
Phone
9921244690
Fax
Email
jayupa.patil6@gmail.com
Details of Contact Person Scientific Query
Name
Dr Sanjay Nipanikar
Designation
Chief Technical Officer (CTO)
Affiliation
Ari Healthcare Pvt. Ltd.
Address
Ari Healthcare Pvt. Ltd. Office No., 107, 1st Floor, S.No.1, World Trade Center, Tower one, Opp. EON SEZ, Kharadi, Pune-, Maharashtra
Pune MAHARASHTRA 411014 India
Phone
8550990792
Fax
Email
sanjay.n@arihealthcare.in
Details of Contact Person Public Query
Name
Dr Sanjay Nipanikar
Designation
Chief Technical Officer (CTO)
Affiliation
Ari Healthcare Pvt. Ltd.
Address
Ari Healthcare Pvt. Ltd. Office No., 107, 1st Floor, S.No.1, World Trade Center, Tower one, Opp. EON SEZ, Kharadi, Pune-, Maharashtra
MAHARASHTRA 411014 India
Phone
8550990792
Fax
Email
sanjay.n@arihealthcare.in
Source of Monetary or Material Support
Ari Healthcare Pvt. Ltd., Office No- 107, World Trade Centre Pune, Tower- 1, Opposite EON SEZ, S.No. 1, Kharadi, Pune- 411014, Maharashtra, India
Primary Sponsor
Name
Ari Healthcare Pvt Ltd
Address
Office No- 107, World Trade Centre Pune, Tower- 1, Opposite EON SEZ, S.No. 1, Kharadi, Pune- 411014, Maharashtra, India
DY Patil College of Ayurved and Research Centre, Pimpri, Pune
OPD No. 2, Ground Floor, Department of Stri-Roga and Prasuti Tantra, Pimpri, Pune-411018 Pune MAHARASHTRA
9921244690
jayupa.patil6@gmail.com
Dr Mauli Vaishnav
Khemdas Ayurveda Hospital, Parul Institute of Ayurved and Research
Department of Stri-Roga & PrasutiTrantra,
OPD No. 5 & 8. Ground Floor,
Khemdas Ayurveda Hospital, Parul Institute of Ayurved and Research, Parul University, AP Limda, Tal – Waghodia, Vadodara, Gujarat - 391760. Vadodara GUJARAT
9589788336
mauli.vaishnav86211@paruluniversity.ac.in
Dr Trupti Kale
Parul Institute of Ayurved, Parul University
OPD No. 104. Ground Floor,
Department of Stri-Roga & Prasuti Trantra, AP Limda, Tal – Waghodia,
Vadodara, Gujarat - 391760
Vadodara GUJARAT
(1) Medicine Name: AHPL/AYLIQ/0717 Syrup, Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Samudga, Duration: 120 Days, anupAna/sahapAna: Yes(details: water), Additional Information: Patients will be asked to take 3 teaspoons full twice daily orally after meals with water for 120 days.
2
Comparator Arm
Drug
Other than Classical
(1) Medicine Name: Marketed Ayurvedic Formulation, Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Samudga, Duration: 120 Days, anupAna/sahapAna: Yes(details: water), Additional Information: Patients will be asked to take 3 teaspoons full twice daily orally after meals with water for 120 days
Inclusion Criteria
Age From
18.00 Year(s)
Age To
40.00 Year(s)
Gender
Female
Details
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.
ExclusionCriteria
Details
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.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pharmacy-controlled Randomization
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Number of subjects achieving regular frequency of menstrual cycle
Day 0, Day 30, Day 60, Day 90 and Day 120.
Secondary Outcome
Outcome
TimePoints
1) Number of subjects achieving regular menstrual bleeding days
2) Changes in amount of menstrual bleeding
3) Abdominal pain (spasm) on VAS
4) Changes in symptoms associated with irregular menstruation
5) Frequency of use of NSAIDs and / or antispasmodic drugs as rescue medications
6) Global assessment for overall change by physician and by patient.
7) Global assessment of tolerability of study drugs
8) Changes in safety laboratory parameters
Day 0, Day 30, Day 60, Day 90 and Day 120.
Target Sample Size
Total Sample Size="86" Sample Size from India="86" Final Enrollment numbers achieved (Total)= "89" Final Enrollment numbers achieved (India)="89"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
It is a randomized,
comparative, double blind, multi-centric prospective, interventional clinical
study to evaluate efficacy and safety of AHPL/AYLIQ/0717 syrup in comparison
with Marketed formulation in participants suffering from menstrual
irregularities. Study will be conducted at 4 to 5 centers in India. Subjects will
be randomly assigned to AHPL/AYLIQ/0717 syrup group or marketed formulation
syrup group in 1: 1 ratio. Subjects will be asked to take given medication in a
dose 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 subjects
achieving regular frequency of menstrual cycle. Secondary objectives of the
study will be to assess number of subjects achieving regular menstrual bleeding days, changes in
amount of menstrual bleeding, abdominal pain (spasm) on VAS, changes
in symptoms associated with irregular menstruation, frequency of use of NSAIDs
and / or antispasmodic drugs as rescue medications, global assessment for
overall change by physician and by patient, global assessment of tolerability
of study drugs and changes in safety laboratory parameters on Day 0, Day 30,
Day 60, Day 90 and Day 120.