| CTRI Number |
CTRI/2024/01/061574 [Registered on: 18/01/2024] Trial Registered Prospectively |
| Last Modified On: |
16/01/2024 |
| 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
|
Treating PCOS using Darchini |
|
Scientific Title of Study
|
Efficacy of hydroalcoholic extract of Darchini (Cinnamomum zeylanicum) in the management of Polycystic Ovarian Syndrome. A randomized control study |
| Trial Acronym |
PCOS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Zeba Saleem |
| Designation |
PG Scholar |
| Affiliation |
Department Of Amraz e Niswan Wa Qabalat, Ajmal Khan Tibbiya College, AMU, Aligarh, U.P., India |
| Address |
Department Of Amraz e Niswan Wa Qabalat, Ajmal Khan Tibbiya College, AMU, Aligarh, U.P., India
Aligarh UTTAR PRADESH 202001 India |
| Phone |
6398703343 |
| Fax |
|
| Email |
zebajaved102021@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Abiha Ahmad Khan |
| Designation |
Assistant Professor |
| Affiliation |
Department Of Amraz e Niswan Wa Qabalat, Ajmal Khan Tibbiya College, AMU, Aligarh, U.P., India |
| Address |
Department Of Amraz e Niswan Wa Qabalat, Ajmal Khan Tibbiya College, AMU, Aligarh, U.P., India
Aligarh UTTAR PRADESH 202001 India |
| Phone |
9620551870 |
| Fax |
|
| Email |
abihaahmad89@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Zeba Saleem |
| Designation |
PG Scholar |
| Affiliation |
Department Of Amraz e Niswan Wa Qabalat, Ajmal Khan Tibbiya College, AMU, Aligarh, U.P., India |
| Address |
Department Of Amraz e Niswan Wa Qabalat, Ajmal Khan Tibbiya College, AMU, Aligarh, U.P., India
Aligarh UTTAR PRADESH 202001 India |
| Phone |
6398703343 |
| Fax |
|
| Email |
zebajaved102021@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Amraz e Niswan Wa Qabalat, Ajmal Khan Tibbiya College, AMU, Aligarh, U.P., India |
|
|
Primary Sponsor
|
| Name |
Department Of Amraz e Niswan Wa Qabalat |
| Address |
Department Of Amraz e Niswan Wa Qabalat, Ajmal Khan Tibbiya College, AMU, Aligarh, U.P., India |
| Type of Sponsor |
Other [ALIGARH MUSLIM UNIVERSITY] |
|
|
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 Abiha Ahmad Khan |
OPD AND IPD OF AJMAL KHAN TIBBIYA COLEGE |
OPD no. 4 and IPD of Gynae ward, Department Of Amraz e Niswan Wa Qabalat, Ajmal Khan Tibbiya College, AMU, Aligarh, U.P., India Aligarh UTTAR PRADESH |
9620551870
abihaahmad89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Ajmal Khan Tibbiya College, Fcaulty of Unani Medicine, Aligarh Muslim University, AMU, Aligarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Darchini Powder |
3 gm Capsule in two divided doses daily for two months |
| Intervention |
Hydroalcoholic extract of Drachini |
200 Mg Capsule Twice Daily For Two Months |
| Comparator Agent |
Metformin |
500 mg tablets twice a day for two months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Married or unmarried females.
Patients who have PCOS diagnosed via Rotterdam criteria. |
|
| ExclusionCriteria |
| Details |
PREGNANT AND LACTATING MOTHERS
PATIENT ON HORMONAL THERAPY
GROSS PELVIC PATHOLOGY AND MALIGNANCY
UNCONTROLLED HYPERTENSION
DIABETES MELLITUS
THYROID DYSFUNCTION |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in serum insulin level,
Change in fasting blood sugar,
Change in OGTT
AMELIORATION OF POLYCYSTIC OVARIES ON USG. |
2 months with followup after every 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in BMI & change in waist hip ratio |
2 months with followup after every 15 days
|
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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
|
N/A |
|
Date of First Enrollment (India)
|
28/01/2024 |
| 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="0" |
|
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
|
PCOS is one of the most common,
complex and heterogenous endocrine disorder affecting 5-10% women of fertile
age. The manifestation of this syndrome includes oligomenorrhoea, amenorrhoea,
anovulation, numerous anteral follicles, hyperandrogenemia and hirsutism. The
syndrrome is defined by the presence of atleast two of the following symptoms
based on the Rotterdam consensus criteria:
a)Oligomenorrhoea/ Anovulation
b) Clinical or
biochemical signs of Hypernadrogenism.
c) Presence of
polycystic ovaries on ultrasound
In unani system of medicine, the disease has not
been mentioned under the term pcos but its translation has been done in arabic
as :"Marz e Ikhyase Khusyaturrahem". This disease has been described
by unani physician under the heading of amenorrhoea, obesity, phlegmatic
disease and liver disorder. Unani concept of PCOS is mainly based on only
dominance of Khilte Balgam (phlegm). One of the abnormal form of balgam is
balgam e mayi which is thinner in consistency and can accumulate in the sacs to
form cyst. A review of unani literature shows that Fue Mizaj e Barid leads to
the combination of sign and symptoms like menstrual abnormalities,
oligomenorrhea, amenorrhoea, hirsutism, obesity, acne, hoarseness of voice and
uqr (infertility) which are sugggestive of PCOS. Due to the unavailability of
safe and effective drugs, scientific evaluation of unani drugs is quiet
necessary. Therefore darchini (Cinnamomum Zeylanicum-arranged from sri lanka)
is selected to study their efficacy in PCOS.The present design will be single
blind, standard control and randomized study and place of study will be Ajmal Khan
Tibbiya College and Hospital with a sample size of 30 patients in each group. The
data will be analyzed by using appropriate statistical tools and will be
presented in the form of tables and graphs.
|