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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  
Name  Address 
NIL   
 
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  
Status 
Not Applicable 
 
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. 

 


 
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