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CTRI Number  CTRI/2021/02/031070 [Registered on: 08/02/2021] Trial Registered Prospectively
Last Modified On: 04/02/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Other 
Public Title of Study   Effect of unani medicine in the treatment of Polycystic Ovarian disease. An open Observational study 
Scientific Title of Study   Effect of Saleekha and Majeeth in Polycystic Ovarian disease. An open Observational study 
Trial Acronym  PCOD 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shabnam Bano 
Designation  PG Scholar 
Affiliation  National Institute of Unani Medicine 
Address  National Institute of Unani Medicine Dept of Ilmul Qabalat wa Amraze Niswan Kottigepalya Magadi Main Road Bengaluru

Bangalore
KARNATAKA
560091
India 
Phone  9027921166  
Fax    
Email  shabnam921166@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Wajeeha Begum 
Designation  Professor and HOD 
Affiliation  National Institute of Unani Medicine 
Address  National Institute of Unani Medicine Dept of Ilmul Qabalat wa Amraze Niswan Kottige palya Magadi Main Road Bengaluru Bangalore

Bangalore
KARNATAKA
560091
India 
Phone  9972550185  
Fax    
Email  drwajeehanium@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Wajeeha Begum 
Designation  professor and HOD 
Affiliation  National Institute of Unani Medicine 
Address  National Institute of Unani Medicine Dept of Ilmul Qabalat wa Amraze Niswan Kottig palya Magadi Main Road Bengaluru

Bangalore
KARNATAKA
560091
India 
Phone  9972550185  
Fax    
Email  drwajeehanium@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Unani Medicine 
 
Primary Sponsor  
Name  National Institute of Unani Medicine 
Address  national Institute of Unani medicine Dept of Ilmul qabalat wa Amraze NiswanKottige palya Magadi Main Road Bengaluru 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
wajeeha begum  INational Institute of Unani medicine  Room No. 29, Dept of Ilmul Qabalat wa Amraze Niswan, Kottigepalya, Magadi Main Road Bangalore KARNATAKA Bangalore KARNATAK Akottigepalya Bangalore KARNATAKA
Bangalore
KARNATAKA 
9972550185

drwajeehanium@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N915||Oligomenorrhea, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Majeeth (Rubia cordifolia) -14gm and Saleekha(Tajkalmi-Cinnamomum cassia)-7gm.   Safoof and Decoction as per standard preparation Safoof of Saleekha 3.5gm BD with Joshanda of Majeeth 7gm BD from 14 days of last menses till 14 days for 3 cycles. Oral  
Comparator Agent  single arm  not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Oligomenorrhoea or amenorrhoea.
USG finding of PCOD.
Obesity
 
 
ExclusionCriteria 
Details  Endometrial tuberculosis.
Malignancies.
Systemic and endocrine diseases.
Pregnancy, lactation and on contraceptive

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
changes in subjective parameter
 
Nature of cycle, duration of cycle, duration of flow, amount of flow.
Clinical sign of hyperandrogenism.
obesity
 
 
Secondary Outcome  
Outcome  TimePoints 
PBAC score
SF-12 survey to assess QOL
BMI and Waist circumference
Ovarian volume
 
After 3 cycles  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   09/02/2021 
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   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Polycystic ovary syndrome (PCOS) is defined as a combination of hyperandrogenism (hirsutism and acne) and anovulation (oligomenorrhorea, infertility, and dysfunctional uterine bleeding) with or without presence of polycystic ovaries on ultrasound. Acanthosis  nigricans most commonly  observed in the neck and intertriginous areas such as armpit, groin and inframammary region7.PCOS is the most common female endocrinologic disorder,  in which ovaries become enlarged with many cysts which are in fact small undeveloped follicles. Over time there is thickening and fibrosis of the ovarian casing which prevents any follicles which do ripen from being released8. It has been considered a progressive multiglandular endocrinopathy where the balance of the hypothalamic pituitary adrenal ovarian axis is disturbed, resulting in failure of the cyclic reproductive mechanism9. Ovulatory dysfunction is typically indicated by unpredictable menses that occur at less than 21-day or greater than 35-day interval however, regular menses that occur every 21 to 35days10.

The Rotterdam criteria indicated PCOS to be present if any 2 of the 3 criteria are met.

1.Oligovulation/anovulation.

 2.Clinical and biochemical signs of hyperandrogenism.

3.Polycystic ovarian morphology(PCOM)seen on ultrasound11.

To evaluate the menstrual flow PBAC a visual representation of blood loss is used12.

SF-12 is a multipurpose short form survey with 12 questions, which are combined, scored, weighted to create two scales that provide glimpses into mental and physical functioning and overall health related quality of life13.

In unani system of medicine the disease has not been defined under the term of PCOS; as the disease has been discovered recently. The description of the disease has come under the heading of ‘Ihtibase al- Tamth’ ‘obesity’, phlegmatic disorder, uqr. Amenorrhoea mostly occurs in fair complexion and phlegmatic temperament female. According to Hippocrates and Galen a women with amenorrhoea develops masculine characteristic, male pattern of hair over the body, beard , hoarseness of voice,  mostly those female who are less muscular with prominent veins.14 Amenorrhoea which is caused by domination of khilte-balgham increases the viscosity. Leading to obesity then treat by mundij-i-balghum  and hot emmenagogue drugs such as maulusul and poste khyarshamber, mushktramashih,  persheoshan,  sudab, babuna15 etc which are widely used. Out of these compound formulation prepared with majeeth, saleekha 16is selected to prove its efficacy in PCOD, as this formula  possess the properties of musakkhin, mulattif, muhallil-i- awram , mudirr-i-bawl wa hayd, mufattih-i-sudad, muqawwi-i-mi’da wa jiger kasire-i-riyah, munaqiye-i- rhem ,munnaqiye-i jiger, munaffith-i-balgham, mu’arriq, muwalid-i- sheer.4,5,6 The unani formulation is being more potent is selected for the study, in the management of PCOD scientifically.

 
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