| 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
|
|
|
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
|
|
|
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. |