Study of the efficacy and safety of DHATREE in polycystic ovary syndrome.
Scientific Title of Study
A Multicenter, Randomized, Double-Blind, Placebo Controlled, Prospective, Clinical Study to Evaluate the Efficacy and Safety Of regime of “DHATHREE†in subjects with polycystic ovary syndrome (PCOS).
Trial Acronym
DHATHREE
Secondary IDs if Any
Secondary ID
Identifier
GHPL-DHT-22-03, version 1.0 dated 06 Sep 2022
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Lakshmikantha G
Designation
Principal Investigator
Affiliation
K R Hospital
Address
Department of Obstetrics and Gynaecology, Cheluvamba ward, MMC and RI K R Hospital, Irwin Rd
Devaraja Mohalla, Yadavagiri, Mysuru Mysore KARNATAKA 570001 India
Phone
Fax
Email
gdrlakshmikantha@gmail.com
Details of Contact Person Scientific Query
Name
Dr Abhijit Munshi
Designation
Director Clinical Operations
Affiliation
Alchemy Clinical Research Services
Address
Room No 3, First Floor, Alchemy Clinical Research Services, 38, LIG So.
Somalwada Road, Manish Nagar
Nagpur
Nagpur MAHARASHTRA 440015 India
Phone
9822371703
Fax
Email
drabhijit@alchemyclinical.in
Details of Contact Person Public Query
Name
Neha Gondhale
Designation
Head Clinical Operations
Affiliation
Alchemy Clinical Research Services
Address
Room No 3, First Floor, Alchemy Clinical Research Services, 38, LIG So.
Somalwada Road, Manish Nagar
Nagpur
705, Quantum Towers Quantum Tower, Rambagh Lane, behind State Bank of India, Malad, Nadiyawala Colony 2, Malad West, Mumbai, Maharashtra 400064
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 3
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
DrLakshmikantha G
K R Hospital
Obstetrics and Gynaecology, Room no 11, Cheluvamba ward, First Floor, K R Hospital Irwin Road Mysore
Mysore
KARNATAKA Mysore KARNATAKA
9740810611
gdrlakshmikantha@gmail.com
Dr Amruta Ladke Babarao
Shalinitai Meghe Hospital & Research Center
OPD no 2, Ground floor Shalinitai Meghe Hospital & Research Center , Wanadongri Hingna, Nagpur-441110 Nagpur MAHARASHTRA
8600031166
amrutaladke2003@gmail.com
Dr Joyti Milind Sadavarte
Sunrise Multispeciality Hospital
Department of Gynaecology, Ground floor, Sunrise Multispeciality Hospital
K and R Nursing Centre Pvt. Ltd., C.S. No 517 A/ 1, Plot No. 71 Eward, Near Hotel K-tree, Shivaji Park, Kolhapur 416001 Kolhapur MAHARASHTRA
2 Placebo herbal capsule one hour after breakfast once a day and 1 Placebo Multivitamin (MVM) Sachets after lunch once a day, for 60 days
Intervention
Regime of DHATREE
2 Herbal capsules one hour after breakfast once a day and 1 Multivitamin (MVM) Sachet after lunch once a day, for 60 days
Inclusion Criteria
Age From
18.00 Year(s)
Age To
40.00 Year(s)
Gender
Female
Details
1.Adult female subjects 18 and 40 (both inclusive) years of age.
2.Subject diagnosed of polycystic ovary syndrome (PCOS), according to Rotterdam Criteria, if she has 2 of the following 3 manifestations:
a) Hyperandrogenism (defined by elevated free testosterone concentration; or Ferriman-Gallwey Score of ≥ 8).
b) Disturbed ovulatory function with chronic oligomenorrhea (cycles of > 35 days, less than nine cycles per year), or amenorrhea (cycle length > 12 weeks) after negative screening pregnancy test.
c)Polycystic ovary as shown by PELVIC ultrasonography.
3.Subjects with established insulin resistance
4.Subject having BMI ≤ 34.9 kg/m2.
5.Subject is willing and able to take oral medications.
6.Subject is willing to continue with regular follow-up as required for the study
7.Subject willing to observe barrier contraception (oral contraceptives or any other hormonal medications not to be consumed) during the study period.
ExclusionCriteria
Details
1.Pregnant or lactating women.
2.Subject with previous medical history or currently having any of the following conditions- Cushing syndrome, late onset of congenital adrenal hyperplasia, androgen-secreting tumors, uncontrolled thyroid disease, hyperprolactinemia; or any other hormonal dysfunction.
3.Subject with history or current status of diabetes mellitus, uncontrolled hypertension, symptomatic cardiovascular diseases.
4.Subject with any acute or chronic infections at the time of screening.
5.Subject with history of malignancies.
6.Subject with known history of gynecological surgery.
7.Subject having impaired renal or liver function at the time of screening.
8.Subject who is currently on a medically-assisted weight loss program with medication or surgical procedures.
9.Subject currently having laparoscopic ovarian diathermy.
10.Subject who is willing to or currently undergoing in vitro fertilization (IVF), or considering participation in any artificial reproduction techniques (ART) program.
11.Subject who has received or is currently receiving following medication within past 3months of screening: clomiphene citrate, insulin sensitizers like Metformin and thiazolidinediones, aromatase inhibitors like anastrozole, letrozole, glucocorticoids, gonadotropins, gonadotropin-releasing hormone agonists, hormonal contraceptives, antiandrogens like spironolactone, cyproterone acetate (CPA), and flutamide, anti-obesity drugs, or any traditional or herbal medicines.
12.Known history or current use of alcohol, smoker or tobacco user, or subject with unstable mental illness.
13.Subject is participating or has participated in any other clinical trial within last 30 days prior to screening.
14.In the opinion of the investigator, the subject is not eligible to participate or may not comply the study procedures.
15.Subject having contraindication or known allergy to any of the study treatment
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
An Open list of random numbers
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
1. Percentage of subjects with improvement in menstrual cycle disturbance at 08 weeks of treatment in DHATREE arm vs. Placebo arm (Note: Improvement in menstrual cycle disturbance should be considered in accordance with FIGO recommendations).
Day 0 to Day 60
Secondary Outcome
Outcome
TimePoints
1. Changes in serum testosterone levels after 08 weeks of treatment
2. Changes in systolic and diastolic blood pressure after 08 weeks of treatment
3. Changes Hip-Waist ratio after 08 weeks of treatment
4. Changes in BMI after 08 weeks of treatment
5. Changes in lipid levels (TC, TG, LDL and HDL) after 08 weeks of treatment
6. Changes in Estradiol/Progesterone/LH/FSH/SHBG after 08 weeks of treatment
7. Percentage of subjects with improvement in Insulin resistance at 08 weeks of treatment in DHATREE arm vs. Placebo arm
Day 0 to Day 60
Target Sample Size
Total Sample Size="68" Sample Size from India="68" Final Enrollment numbers achieved (Total)= "68" Final Enrollment numbers achieved (India)="68"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a Multicenter, Randomized, Double-Blind, Placebo Controlled, Prospective, Clinical Study to Evaluate the Efficacy and Safety Of regime of “DHATHREE†in subjects with polycystic ovary syndrome (PCOS). Subjects fulfilling the inclusion and exclusion criteria will be enrolled in the study. Enrolled subjects will be under treatment for 12 weeks.The study will include 2 periods for a total of up to 13 weeks: Subjects who meet all the eligibility criteria, based on medical history and clinical examination will be recruited in this study. The duration of a subject’s participation will be approximately 3 months’ in the study. Screening Visit: Visit 1(Day-28 to Day 0) ·Screening assessments may be performed for up to 28 days prior to randomization. Randomization will occur once all screening assessments are complete, and subject’s eligibility for participation is confirmed. ·The following assessments will be done prior to randomization: ·Obtaining Written informed consent (prior to any study-specific procedure) ·Collection of demographic, medical and medication history and personal history ·Physical examination complete general examination, measurements of weight, height, BMI, waist and hip circumference measurement. ·Notes: ØWaist circumference will be measured midway between lower rib margin and the iliac crest in the mid-axillary line at the end of normal expiration. ØHip circumference will be measured with the measuring tap at the highest prominence of the buttock sand parallel to the floor. ·Menstrual history: Regularity of menses: cycle to cycle variation over ·12 months, frequency of menses, heaviness of menstrual flow, and duration of menstrual flow ·Vital signs (pulse rate, respiratory rate, blood pressure, body temperature) ·Assessment of eligibility criteria ·Laboratory assessments: hematology, fasting blood glucose (FBG), PPBG, IR, lipid profile (TC, HDL, LDL, TG), Sex hormone binding globulin (SHBG), Hormone profile* (Luteinizing hormone, FSH, Estradiol,Progesterone), Serum Testosterone level,17-Hydroxy progesterone and urinalysis ·*Hormone profile: ·On Day 02 and on Day 03 of menstrual cycle: FSH, LH and Estradiol ·On Day 21 of menstrual cycle -Progesterone ·Serum Pregnancy test ·Pelvic ultrasound will be performed at screening for determining the eligibility of the Subject, if a recent report is not available(within 3 months) ·Once above assessments are completed and subject’s eligibility is confirmed, following procedures will be performed: Visit-02: Randomization (Day 01): Treatment allocation either Dhatree or Placebo ·Allocation and dispensing of study treatment, and subject diaries ·Prior and concomitant medications recording ·Adverse event recording and reporting, as applicable ·Urine Pregnancy Test The subject will be followed up at Visit 3: (Day 15 ± 2) (Telephonic)Visit 4: Interim (Day 30 ± 3)Visit 5: Follow up 3 (Day 45 ± 2) (Telephonic)Visit 6: End of Study (EOS)assessment (Day 60 ± 3) The following assessments will be performed at each of these clinic study visits: oEvaluation of menstrual frequency & improvement in frequency of menstruation– ·Physical examination, complete general examination, measurements of weight, and hip and waist circumferences and BMI. ·Vital signs measurements (pulse rate, respiratory rate, blood pressure, body temperature) ·Laboratory assessments: ØAt screening and Week 8: Hematology, lipid profile (TC, HDL, LDL, TG), Hormone profile* (Luteinizing hormone, FSH, Estradiol, Progesterone), PPBG, IR, Sex hormone binding globulin (SHBG), Serum Testosterone level,17-Hydroxy progesterone and urinalysis ØUrine Pregnancy Test. ØFasting Blood Glucose level-at all site visits ·Dispensing of study medication at Visit-02 and 04 ·Reviewing Subject diaries ·Prior and Concomitant medications recording ·Adverse event recording and reporting, as applicable ·Final accountability of study treatment/tablets and retrieval at week 8. ·Return of subject dairy at week 8. ·Subjects who test positive for pregnancy any time during the study will be discontinued from the study, and will be followed up by the investigator as per regulatory requirement.