| CTRI Number |
CTRI/2020/11/028824 [Registered on: 03/11/2020] Trial Registered Prospectively |
| Last Modified On: |
02/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to find Effects of Chandraprabha Vati(Ayurvedic Medicine) in Polycystic Ovarian Syndrome Characterised by Small cysts in ovary with irregular,Scanty menses and excess/unwanted hairs on Face,Thighs,Abdomen etc.
|
|
Scientific Title of Study
|
“Randomized controlled clinical trial to study the efficacy OF Chandraprabha vati in PCOS.†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Niranjan Ashok Dumbare |
| Designation |
Assistant Professor(Prasutitantra and Strirog) |
| Affiliation |
Ashtang Ayurved College,Pune.30 |
| Address |
868,Prasutitantra And Strirog Department.
Ashtang Ayurved Hospital and Research Centre 2062,Opp.NMV Girls Highschool, Sadashiv Peth,Pune
Pune
MAHARASHTRA
411030
India |
| Phone |
9890201717 |
| Fax |
|
| Email |
drniranjan417@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayashri S Deshmukh |
| Designation |
Professor(Prasutitantra) |
| Affiliation |
CSMSS Ayurved Mahavidyalay Aurangabad. |
| Address |
CSMSS Ayurved Hospital and Research centre, Kanchanwadi,Aurangabad.
Aurangabad MAHARASHTRA 431002
Aurangabad
MAHARASHTRA
431002
India |
| Phone |
9325580777 |
| Fax |
|
| Email |
dr.jayashrisdeshmukh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Niranjan Ashok Dumbare |
| Designation |
Assistant Professor(Prasutitantra and Strirog) |
| Affiliation |
Ashtang Ayurved College Pune.30 |
| Address |
868,Prasutitantra And Strirog Department.
Ashtang Ayurved Hospital and Research Centre 2062,Opp.NMV Girls Highschool, Sadashiv Peth,Pune.
Pune
MAHARASHTRA
411030
India |
| Phone |
9890201717 |
| Fax |
|
| Email |
drniranjan417@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ashtang Ayurved Hospital And Research Centre.Pune.30 |
|
|
Primary Sponsor
|
| Name |
Niranjan Ashok Dumbare |
| Address |
Ashtang Ayurved Hospital and Research Centre, 2062,Opp.NMV Girls Highschool,Sadashiv Peth,Pune.30 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| CSMSS Ayurved Mahavidyalaya |
CSMSS Ayurved Hospital and Research centre, Kanchanwadi,Aurangabad.
Aurangabad |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Niranjan Ashok Dumbare |
CSMSS Ayurved Hospital |
Strirog Prasutitantra Dept.OPD
Aurangabad
MAHARASHTRA |
9890201717
drniranjan417@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,CSMSS Ayurved College,Kanchanwadi,Aurangabad.431002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E282||Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chandraprabha Vati |
500 mg 1 BD with Luke warm water.Just before food.Orally For 6 months. |
| Comparator Agent |
Metformin Hydrochoride inthe Form of Tablet. |
500 mg 1 TDS (500 mg 1 OD for 1st week then 500 mg 1 BD for 2nd week thereafter 500 mg 1 TDS with water),Just before food Orally for 6 Months. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Patients of age group 19-35 years.
2.Diagnosed cases of PCOS (Rotterdam Criteria) Any 2/3
a)Hyperandrogenism (Clinical or Biochemical)
b)Oligomenorrhea (Menstrual cycle > 35days)/ Secondary Amenorrhea (Menstrual cycle > 90 days but<180 days)
c) USG findings– PCO features on USG i.e. Peripherally arranged Antral Follicle Count >12 with thickened stroma in Ovaries And OR Ovarian Volume >10 cm3 in Unilateral or Bilateral ovaries.
3.Both Unmarried and Married patients of PCOS.
|
|
| ExclusionCriteria |
| Details |
1.Patients of age group < 19 yrs and > 35 yrs.
2.Patients showing signs and symptoms other than PCOS.
3.Patients having any other disease causing Oligomenorrhea & Anovulation excluding PCOS on above criteria i.e.Hypogonadotrophic Hypogonadism, Premature Ovarian Failure.
4.Patients suffering from a) Congenital Adrenal Hyperplasia b) Severe Insulin resistance(Insulin dependant Diabetes Mellitus) c)Androgen secreting Ovarian & Adrenal tumors d)Thyroid abnormalities e) Cushing’s syndrome f)Cardiac disease g) Hyperprolactenemia
5.Patients with any organic lesions of Reproductive Tract like TB, Ca, Congenital anomalies, any other pelvic pathologies.
6.A current or previous (within 3 months) use of OC Pills, Glucocorticoids, Antiandrogens, Antidiabetics, Antiobesity drugs or any Hormonal Therapy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Menstrual History For Interval between 2 cycles. 2.modified Ferriman Gallwey Score for Hirsutism |
At Enrollment and After 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
BMI IN KG/M2
Sr.Testesterone Sr.Insulin (F) BSL(F)
USG (Pelvis)TAS OR TVS
1)PCOS Pattern 2)Ovarian volume
|
At Enrollment and After 6 months |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
16/11/2020 |
| 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="11"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomize,Parallel group,Single
blind,Clinical trial with Active control i.e Standard Control,to study the
Safety & Efficacy of Chandraprabha Vati(Ayurvedic Formulation in Tablet
Form) 500 mg twice daily for 6 months with Luke warm water just before food in
70 patients with Polycystic Ovarian Syndrome which will have Active Control
group included Tablet Metformin Hydrochloride 500 mg thrice a day with water
just before food in 70 Patients for 6 months in 2 centers in India.The Primary
outcome 1) Menstrual History For Interval between 2 cycles 2)modified Ferriman Gallwey Score (Hirsutism) will be measures At Enrollment & After 6 Months. The Secondary
outcome ,BMI IN KG/M2,Sr. Testesterone,Sr. Insulin (F),BSL(F),USG (Pelvis)TAS
OR TVS for 1)PCOS Pattern2)Ovarian volume, will be measures At Enrollment & After 6 Months.
|