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CTRI Number  CTRI/2022/09/045921 [Registered on: 27/09/2022] Trial Registered Prospectively
Last Modified On: 30/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Infertility treatment  
Scientific Title of Study   A comparative clinical study of unani medicine and clomiphene citrate in induction of ovulation(istiqra-e-ibaza) 
Trial Acronym  Nill 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrNida Firdous 
Designation  PG SCHOLAR 
Affiliation  Govt.Nizamia Tibbi college and General hospital 
Address  PG Dept.of OBSTETRICS and Gynaecology, Govt.Nizamia Tibbi college and General Hospital, charminar,Hyd.
PG Dept.of OBSTETRICS and Gynaecology, Govt.Nizamia Tibbi college and General Hospital, charminar,Hyd.
Hyderabad
TELANGANA
500002
India 
Phone  8247006617  
Fax  00  
Email  dr.nida011@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr SYEDA ABIDUNNISA 
Designation  Professor 
Affiliation  Govt.Nizamia Tibbi college and General hospital 
Address  PG department of obstetrics and Gynaecology(ilmul qabalath wo amraze niswan) Govt.Nizamia Tibbi college and General Hospital, charminar,Hyd.
PG department of obstetrics and Gynaecology(ilmul qabalath wo amraze niswan) Govt.Nizamia Tibbi college and General Hospital, charminar,Hyd.
Hyderabad
TELANGANA
500002
India 
Phone  9492027082  
Fax  00  
Email  syedaabidunnisa@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrNida Firdous 
Designation  PG Scholar 
Affiliation  Govt.Nizamia Tibbi college and general hospital 
Address  PG Dept.of OBSTETRICS and Gynaecology, Govt.Nizamia Tibbi college and General Hospital, charminar,Hyd.
PG Dept.of OBSTETRICS and Gynaecology, Govt.Nizamia Tibbi college and General Hospital, charminar,Hyd.
Hyderabad
TELANGANA
500002
India 
Phone  8247006617  
Fax  00  
Email  dr.nida011@gmail.com  
 
Source of Monetary or Material Support  
PG Dept.of OBSTETRICS and Gynaecology, Govt.Nizamia Tibbi college and General Hospital, charminar,Hyd. 
 
Primary Sponsor  
Name  GovtNizamia Tibbi college and general hospital 
Address  PG Dept.of OBSTETRICS and Gynaecology, Govt.Nizamia Tibbi college and General Hospital, charminar,Hyd. 
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 
DrNida Firdous   GovtNizamia Tibbi college and General Hospital  Department of obs & gynaecology New block Charminar, Hyderabad
Hyderabad
TELANGANA 
8247006617
00
dr.nida011@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: E289||Ovarian dysfunction, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  INDUCTION OF OVULATION WITH THE HELP OF UNANAI MEDICINE  EACH PATIENT OF GROUP A WILL BE TREATED WITH UNANI MEDICINE(ORAL MEDICINE-POWDER FORM OF 5 GRAM bd of all medicines)1.CURCULIGO ORCHIOIDES(MUSLI SIAH) 2)CHLOROPHYTUM BORIVILIANUM (MUSLI SAFED) 3)TRIBULUS TERRESTRIS (GHOKRU) 4)BLEPHARIS EDULIS PERS (TUKHME UTANGAN) 5)SALMALIA MALABARICA(POSTE BEEKHE SEMBHEL)AND VAGINAL SUPPOSITORY OF 1)ACHILLEA MILEFOLIUM(BARANJASIF)-5 GRAMS 5 DAYS EACH CYCLES(3) ALONG WITH CONTROL GROUP TREATED WITH CLOMIPHENE CITRATE 50 mg od FOR 3 CYCLES FOR 5 DAYS FOR EACH PATIENT  
Comparator Agent  INDUCTION OF OVULATION WITH THE HELP OF UNANI MEDICINE ALONG WITH COMPARISION OF CLOMIPHENE CITRATE  EACH PATIENT OF GROUP A WILL BE TREATED WITH UNANI MEDICINE(ORAL MEDICINE AND VAGINAL SUPPOSITORY) 5 DAYS EACH CYCLES(3) ALONG WITH CONTROL GROUP B TREATED WITH CLOMIPHENE CITRATE FOR 3 CYCLES FOR 5 DAYS FOR EACH PATIENT  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  MARRIED WOMEN
PATIENTS WITH MENSTRUAL IRREGULARITIES
PCOS
PATIENTS WITH ANOVULATORY INFERTILITY 
 
ExclusionCriteria 
Details  AGE <18 AND >40
MALE AND CHILDREN
UNMARRIED WOMEN
PATIENT WITH SYSTEMIC DISEASES(CVA,CAD,COPD,D.M,HTN)
PATIENT WITH CONGENITAL DEFECTS 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
GROUP A EACH PATIENT OUTCOME DEPENDS ON AFTER 3 CYCLES OF SUCESSFULL ORAL MEDICNE AND VAGINAL SUPPOSITORY of unani medicine (LOCAL MEDICINE) i.e90 days GROUP B OUT COME DEPENDS ON EACH PATIENT SUCESS FULL ORAL MEDICINE(CLOMIPHENE CITRATE) FOR 3 CYCLE ,With the help of ovulation study and Necessary hormonal assy test i.e for 90 days.which can be absorbed with the help of u/s whole Abdomen and pelvis before and during and after treatment   GROUP A EACH PATIENT OUTCOME DEPENDS ON AFTER 3 CYCLES OF SUCESSFULL ORAL MEDICNE i.e 90 days AND VAGINAL SUPPOSITORY(LOCAL MEDICINE) GROUP B OUT COME DEPENDS ON EACH PATIENT SUCESS FULL ORAL MEDICINE(CLOMIPHENE CITRATE) FOR 3 CYCLE i.e 90 days 
 
Secondary Outcome  
Outcome  TimePoints 
GROUP A EACH PATIENT OUTCOME DEPENDS ON AFTER 3 CYCLES OF SUCESSFULL ORAL MEDICNE AND VAGINAL SUPPOSITORY(LOCAL MEDICINE) i.e for 90 days GROUP B OUT COME DEPENDS ON EACH PATIENT SUCESS FULL ORAL MEDICINE(CLOMIPHENE CITRATE) FOR 3 CYCLE i.e 90 days. The out will be absorbed with the help of u/s whole Abdomen and pelvis before, during and after treatment   GROUP A EACH PATIENT OUTCOME DEPENDS ON AFTER 3 CYCLES OF SUCESSFULL ORAL MEDICNE AND VAGINAL SUPPOSITORY(LOCAL MEDICINE) GROUP B OUT COME DEPENDS ON EACH PATIENT SUCESS FULL ORAL MEDICINE(CLOMIPHENE CITRATE) FOR 3 CYCLE i.e 90 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   10/10/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/10/2022 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   nill 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Ovulation is the central event in female reproduction.
Coordinated effects of hypothalamic gonadotropin releasing hormone, pituitary gonadotropins, ovarian estrogen and follicular response to these effects result in ovulation.
Any derangement of above factors results in ovarian dysfunction. The concept of ovulation has been mentioned in Unani encyclopedia by ancient Unani physicians’ centuries ago.
Ibaza is the term framed from Arabic dictionary for ovulation.

In classical Unani literature :
Literally, the word istiqrae means induction and ibaza means ovulation.
The description of adam ibaza (anovulation) has been mentioned under the heading of uqr.
Synonyms of Uqr:
-Uqm 
-Banjhpan
-Adam hamal
-Butlan habal 
-Usre habal
-Istiqrare hamal na hona 
-Hamal na hona 

INCIDENCE:-

Today nearly 30% to 40% of the infertile patients suffer from ovulatory dysfunction in which 75% of have polycystic ovaries and 20 to 25% of women with normal ovulation.



ETIO-PATHOGENESIS:-

An ovulation is a relatively common clinical disorder which may manifest as disordered cycle regularly or amenorrhea or in association with other symptoms such as hirsutism or galactorrhea.Disturbance at any level of HPO axis and feedback mechanism may inhibit the oocyte maturation and release, some of the abnormalities are amenable to treatment while some others like ovarian failure secondary to oocyte depletion are intractable.
Therefore it is useful to segregate the various causes of An ovulation into following compartments :

1.HYPOTHALAMIC:-

Hypogonadotrophic hypogonadism
Obesity
Kallman’s syndrome
Stress
Idiopathic



2.PITUITORY:-

Hyperprolactinaemia
Pituitory failure [hypogonadotrophic hypogonadism]
Sheehan’s syndrome
Craniopharyngioma
Cerebral radiotheraphy

3.OVARIAN:-

Polycystic ovaries
premature ovarian failure

4.OTHERENDOCRINE:-

Hypothyroidism
 Congenital adrenal hyperplasia


CLINICAL FEATURES

SIGN AND SYMPTOMS :-
patient may present with :
Asymptomatic 
 Menstrual irregularities like oligomenorrhoea (or) amenorrhea
Galactorrhoea 
 Infertility 
 Hyperandrogenism may present clinically as hirsutism,acne or male pattern alopecia 
Obesity
g.   Aging (older women) 
h.   Hyperprolactinemia

COMPLICATION:-

The serious consequences of chronic an ovulation are infertility and a greater risk for developing carcinoma of the endometrium.

UNANI CONCEPT:-

In classical Unani literature,various physicians mentioned the detailed description of  female genital organs. Soranus and Ephesus[98-138 AD] Father of gynaecology,gave a detailed description about ovaries noting their shape,size and position.He believed that conception was most likely to take place directly after menstruation.He mentioned that ovaries were attatched to uterus and were not of firm consistency but glandular and covered with membrane.
Arastu and jalinoos mentioned that both male mani (sperm) and female mani (ovum) are responsible for conception. Jalinoos states that if both baiza (ovaries)of any animal are either excised or crushed or make it colder with shokran,then conception will not take place.

According to famous Unani physician buqrat,  the cause of Anovulation is defect in mani(ovum)
Uqr is defined as when conception fails to occur or when there is a difficulty in conception either due to the defect in male or female partner.
 Defect in female partner are attributed to the diseases of aazae mani (ovaries), rehm (uterus) or nafsani (psychological)

ASBAAB (ETIOLOGY)

Causes of uqr in female are broadly classified into following categories. 

1. Defect in aazae mani (ovaries): 
Decreased in the quantity of mani (ovum) i.e: oligo or anovulation.
Sue mizaj mukhtalif of mani (haar, barid or ratab)
Warm khusiyatur rehm (oophoritis)

2. Rehm (uterus):
Sue mizaj rehm (haar, barid, ratab or yabis)
Futoorat haiz (menstrual irreglariti…
 
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