| CTRI Number |
CTRI/2024/06/069385 [Registered on: 24/06/2024] Trial Registered Prospectively |
| Last Modified On: |
21/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Persiyawashan in Polycystic Ovarian Syndrome |
|
Scientific Title of Study
|
Efficacy of Persiyawashan on ovarian volume in
Polycystic Ovarian Syndrome A randomized
controlled study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Samira Khatoon Choudhary |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Unani Medicine |
| Address |
OPD-29,Ilmul Qabalat wa Amraz e Niswan, National Institute of Unani Medicine, Kottigepalya, Magadi Main road, Bangalore
National Institute of Unani Medicine, Kottigepalya, Magadi Main road, Bangalore
Bangalore
KARNATAKA
560091
India |
| Phone |
08454018655 |
| Fax |
|
| Email |
samira01choudhary@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Wajeeha Begum |
| Designation |
Professor |
| Affiliation |
National Institute of Unani Medicine |
| Address |
OPD-29,Ilmul Qabalat wa Amraz e Niswan, National Institute of Unani Medicine, Kottigepalya, Magadi Main road, Bangalore
National Institute of Unani Medicine, Kottigepalya, Magadi Main road, Bangalore
Bangalore
KARNATAKA
560091
India |
| Phone |
9972550185 |
| Fax |
|
| Email |
drwajeehanium@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Wajeeha Begum |
| Designation |
Professor |
| Affiliation |
National Institute of Unani Medicine |
| Address |
OPD-29,Ilmul Qabalat wa Amraz e Niswan, National Institute of Unani Medicine, Kottigepalya, Magadi Main road, Bangalore
National Institute of Unani Medicine, Kottigepalya, Magadi Main road, Bangalore
KARNATAKA
560091
India |
| Phone |
9972550185 |
| Fax |
|
| Email |
drwajeehanium@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Unani Medicine, Kottigepalya magadi main road, bengaluru, karnataka, india, 560091 |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine |
| Address |
National Institute of Unani Medicine, Kottigepalya, Magadi Main road, Bangalore
National Institute of Unani Medicine, Kottigepalya, Magadi Main road, Bangalore |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Samira Khatoon Choudhary |
National Institute of Unani Medicine |
OPD-29,Ilmul Qabalat wa Amraz e Niswan, National Institute of Unani Medicine, Kottigepalya, Magadi Main road, Bangalore
National Institute of Unani Medicine, Kottigepalya, Magadi Main road, Bangalore
Bangalore
KARNATAKA |
08454018655
samira01choudhary@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe for Biomedical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N839||Noninflammatory disorder of ovary,fallopian tube and broad ligament, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Persiyawashan (Adiantum capillus veneris Linn.) |
Decoction of parsiyawashan 10 gms will be prepared as per standard
preparation. Orally BD before food. 5day before expected date of menses for 10
day. |
| Comparator Agent |
Tab. Metformin 500 mg |
Tab. Metformin 500 mg orally before food twice a day. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
42.00 Year(s) |
| Gender |
Female |
| Details |
Both unmarried and married female patients between 18-42 year of age.
Fulfilling Rotterdam’s criteria (clinical hyperandrogenism or biochemical
hyperandrogenism, evidence of oligo-amenorrhea, polycystic appearing-ovarian
morphology on ultrasound) |
|
| ExclusionCriteria |
| Details |
Patients with systemic Hypertension, Diabetes mellitus and endocrine diseases like thyroid dysfunction and hepatic disorders.
Pregnant and lactating women.
Patient on hormonal contraceptives (use within 3 months).
Patients with history of malignancies, endometrial tuberculosis, uterine fibroid more than 3 centimeter,
other ovarian cyst more than 2 centimeters |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in ovarian volume, Modified Ferriman Gallwey score,
acanthosis nigricans, SF 12 QOL, BMI. |
0,1,2,3,4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Menstrual regulation. |
0,1,2,3,4 months |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
02/07/2024 |
| 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="6"
Days="5" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Polycystic ovarian syndrome (PCOS) is the most well-known heterogeneous
endocrine disorder in women of reproductive age with speculative etiology, causing
a wide range of reproductive, metabolic, endocrine, and psychological effects.
Among them are ovulatory dysfunction, menstrual irregularities, infertility,
hyperandrogenism, increased insulin level, obesity, obstructive sleep apnea, non
alcoholic fatty liver, eating and mood disorders, cardiovascular disease (CVD) and
an increased risk of type 2 diabetes mellitus (T2DM) are significant factors. Polycystic ovary syndrome (PCOS) is one of the most common endocrine
conditions, affecting 8–13% of women and 3.4–19.6% of adolescent girls. The
highest prevalence (19.6%) was reported in adolescents with type 2 diabetes. patients with PCOS have alterations in several reproductive pathways independently
of their ovulatory status. These include primary and secondary alterations of the
oocyte and embryo quality, and of endometrial competence.3The major etiology
behind PCOS is primary disordered gonadotropin secretions, ovarian and adrenal
hyperandrogenism and disorder of insulin resistance. This can be treated with medications such as clomiphene citrate, tamoxifen,
aromatase inhibitors, metformin, glucocorticoids, gonadotropins or surgically by
laparoscopic ovarian drilling. these drugs and methods have their own side effects.
This disease has been described by Unani physician under the heading of
amenorrhea, obesity and phlegmatic disease. Unani concept of PCOD is mainly
based on the dominance of khilt balgham (phlegm). Sū-i-mizāj barid of the liver may
leads to abnormal production of phlegm, one of the abnormal forms of phlegm is
balgham mā’ī, which is thinner in consistency and can accumulate in sacs to form
cysts., In unani system of medicine, many drugs are prescribed for amenorrhea
which can be used in treatment of PCOS, like parsiyawashan, darchinin,
kharkhasak, zanjabeel, abhal, mushktramashi, alsi, kalonji etc. Parsiyawashan has
been considered for trial having mudirr-i-bawl wa hayd, mudirr-i-nafas, mufattih wa
mudij-i-balgham, muhallil, mulattif etc. Also it possess many properties like
antidiabetic, hypo-cholesterolemic, anti-obesity, anti-thyroidal effect, and
antioxidant. It is easily available, cost effective and having less side effects. Hence
it has been selected to evaluate the effect in PCOS. |