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CTRI Number  CTRI/2025/04/084079 [Registered on: 03/04/2025] Trial Registered Prospectively
Last Modified On: 01/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of Satavar (Asparagus racemosus) in patients having post-menopausal symptoms. 
Scientific Title of Study   Clinical Efficacy of Satavar (Asparagus racemosus) in Post-Menopausal Syndrome (Mutlazima Sinne Yaas) - A randomized placebo control single blind study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SUMAIYYA KHANAM 
Designation  PG SCHOLAR 
Affiliation  ALIGARH MUSLIM UNIVERSITY 
Address  DEPARTMENT OF NISWAN-WA-QABALAT, AJMAL KHAN TIBBIYA COLLEGE, A.M.U., ALIGARH, UTTAR PRADESH.

Aligarh
UTTAR PRADESH
202001
India 
Phone  9149255642  
Fax    
Email  sumaiyya234@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  PROF SYEDA AAMENA NAAZ 
Designation  PROFESSOR 
Affiliation  ALIGARH MUSLIM UNIVERSITY 
Address  DEPARTMENT OF NISWAN-WA-QABALAT, AJMAL KHAN TIBBIYA COLLEGE, A.M.U., ALIGARH, UTTAR PRADESH.

Aligarh
UTTAR PRADESH
202001
India 
Phone  9412672189  
Fax    
Email  syedanaaz@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  PROF SYEDA AAMENA NAAZ 
Designation  PROFESSOR 
Affiliation  ALIGARH MUSLIM UNIVERSITY 
Address  DEPARTMENT OF NISWAN-WA-QABALAT, AJMAL KHAN TIBBIYA COLLEGE, A.M.U., ALIGARH, UTTAR PRADESH.

Aligarh
UTTAR PRADESH
202001
India 
Phone  9412672189  
Fax    
Email  syedanaaz@yahoo.com  
 
Source of Monetary or Material Support  
ALIGARH MUSLIM UNIVERSITY 
 
Primary Sponsor  
Name  SUMAIYYA KHANAM 
Address  PG SCHOLAR, DEPARTMENT OF NISWAN-WA-QABALAT, AJMAL KHAN TIBBIYA COLLEGE AND HOSPITAL, AMU, ALIGARH 
Type of Sponsor  Other [SELF] 
 
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 
SUMAIYYA KHANAM   AJMAL KHAN TIBBIYA COLLEGE AND HOSPITAL, A.M.U. ALIGARH  OPD AND IPD OF DEPARTMENT OF NISWAN-WA-QABALAT,AJMAL KHAN TIBBIYA COLLEGE AND HOSPITAL, A.M.U. ALIGARH.
Aligarh
UTTAR PRADESH 
9149255642

sumaiyya234@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N951||Menopausal and female climactericstates,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  POWDERED SATAVAR  5gm POWDER OF SATAVAR TWICE DAILY FOR 3 MONTHS. THIS DRUG HAVE PHYTOESTROGENIC PROPERTIES ALONG WITH MUQAWWI-E-QALB (CARDIAC TONIC), MUHALLIL-E-WARM (ANTI-INFLAMMATORY), EMOLLIENT, COOLING, NERVINE TONIC, ANTI-DEPRESSANT, DIURETIC, REJUVENATING, CARMINATIVE, STOMACHIC, ANTISPASMODIC, ANTISEPTIC, ANTIOXIDANT AND HEPATOPROTECTIVE ACTIVITY. 
Comparator Agent  ROASTED WHEAT FLOUR  5gm ROASTED WHEAT FLOUR POWDER TWICE DAILY FOR 3 MONTHS.THIS WILL BE GIVEN AS PLACEBO TO COMPARE THE EFFECT OF INTERVENTION DRUG. 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  PATIENTS WITH HISTORY OF AMENORRHOEA FOR 1 YEAR ASSOCIATED WITH HOT FLASHES ALONG WITH MORE THAN OR EQUAL TO 3 SYMPTOMS THAT ARE MENTIONED IN THE GREENE CLIMACTERIC SCALE 
 
ExclusionCriteria 
Details  PATIENT HAVING AMENORRHEA DUE TO OTHER PATHOLOGY,OR SUFFERING FROM HTN, TB, CANCER, DM, THYROID DISORDER, STI, LIVER AND KIDNEY DISEASE, ESTABLISHED CASES OF ANY MAJOR PSYCHIATRIC DISORDER SUCH AS SCHIZOPHRENIA AND MENTAL RETARDATION, PATIENT ON HORMONE REPLACEMENT THERAPY WITHIN 60 DAYS OF STUDY PERIOD OR POST-MENOPAUSAL BLEEDING. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
RELIEF IN HOT FLASHES AND OTHER ASSOCIATED SYMPTOMS OF POST MENOPAUSAL SYNDROME  SYMPTOMS WILL BE ASSESSED AT THE INITIATION OF THE STUDY AND MONTHLY FOR 3 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
IMPROVEMENT IN GREENE CLIMACTERIC SCALE
IMPROVEMENT IN QUALITY OF LIFE (QOL) QUESTIONNAIRE
IMPROVEMENT IN MENOPAUSE SPECIFIC TREATMENT SATISFACTION QUESTIONNAIRE (MS-TSQ)
CHANGES IN SERUM ESTRADIOL LEVEL 
GREEN CLIMACTERIC SCALE,QOL QUESTIONNAIRE, MS-TSQ WILL BE ASSESSED AT THE INITIATION OF THE STUDY AND MONTHLY FOR 3 MONTHS AND SERUM ESTRADIOL LEVEL WILL BE DONE BEFORE AND AFTER TREAMENT 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   Phase 2 
Date of First Enrollment (India)   14/04/2025 
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  

CLIMACTERIC IS THE PHASE OF WANING OVARIAN ACTIVITY AND MAY BEGIN 2-3 YEARS BEFORE MENOPAUSE AND CONTINUE FOR 2-5 YEARS AFTER IT. THUS, THE CLIMACTERIC IS THE PHASE OF ADJUSTMENT BETWEEN ACTIVE AND INACTIVE OVARIAN FUNCTION AND IT INVOLVES PHYSICAL, SEXUAL AND PSYCHOLOGICAL ADJUSTMENTS.

MENOPAUSAL SYMPTOMS INCLUDE HOT FLASHES CHARACTERIZED BY SUDDEN FEELING OF HEAT FOLLOWED BY PROFUSE SWEATING WHICH IS THE DOMINANT AND CLASSICAL SYMPTOM. OTHER SYMPTOMS ARE INCONTINENCEURGENCY OF URINE, VAGINAL DRYNESS, PAINFUL INTERCOURSE, DECREASE LIBIDO, SKIN DRYNESS AND WRINKLING, JOINT STIFFNESS & SORENESS, OSTEOPOROSIS. PSYCHOLOGICAL SYMPTOMS INCLUDE DEPRESSION, HEADACHE, INSOMNIA, ANXIETY, MENTAL CONFUSION, IRRITABILITY, CAN ALSO OCCUR IN POST-MENOPAUSAL WOMEN. IN ADDITION TO THESE, FEMALES ARE AT HIGH RISK OF DEVELOPING ISCHEMIC HEART DISEASES, CORONARY ARTERY DISEASES, BREAST CANCER, OSTEOPOROSIS AND FRACTURE IN FUTURE.

IT IS A MAJOR PROBLEM OF ELDERLY WOMEN POSSESSING BOTH PSYCHIC & SOMATIC SYMPTOMS, WHICH CREATE TROUBLES IN DAILY BEHAVIOR & MAINTAINING THE HEALTHY LIFE. NUMBER OF MENOPAUSAL WOMEN IN INDIA IS 43 MILLION. IT IS PREDICTED THAT THE TOTAL NUMBER OF POST- MENOPAUSAL WOMEN IN 2030 WILL BE APPROXIMATELY 1200 MILLION & THE PROPORTION OF THOSE LIVING IN THE DEVELOPING COUNTRIES WILL BE NEARLY 76% .

FOLLOWING MENOPAUSE THERE IS A SHARP FALL IN ESTROGEN (66%) AND ANDROGEN (50%) CAUSING REBOUND INCREASE IN FOLLICLE STIMULATING HORMONE AND LUTEINIZING HORMONE, HENCE THERE IS DISTURBANCES IN THE PHYSIOLOGICAL AND METABOLIC FUNCTIONS OF BODY.

UNANI SYSTEM OF MEDICINE IS ENRICHED WITH THE CONCEPT OF EHTIBAS-E-HAIZ (AMENORRHOEA) BUT THERE IS NO EXACT DESCRIPTION OF MENOPAUSE, NEVERTHELESS IT MAY REVEALED UNDER EHTIBAS-E-TAMS AND CAN BE CORRELATED WITH SIN-E-YAAS (AGE OF NATURAL TERMINATION OF MENSTRUATION).

ESTROGEN LEVEL FALLS OVER THE 5 YEARS PRECEDING OVARIAN FAILURE, WHICH OCCURS USUALLY BETWEEN 45 AND 55 YEARS OF AGE, WITH AN AVERAGE OF AROUND 50 YEARS. THE ABOVE MENTIONED AGE GROUP IN UNANI LITERATURE IS DESCRIBED AS SIN-E-KAHOOLAT WHICH STARTS AT AROUND 35-40 YEARS OF AGE AND LASTS ABOUT 60 YEARS OF AGE. ACCORDING TO ZAKARIA RAZI, PHYSIOLOGICAL AMENORRHEA MAY TAKE PLACE BETWEEN 40 TO 60 YEARS OF AGE. HE FURTHER MENTIONED IN HIS BOOK THAT SUCH CONDITION COMES INTO EXISTENCE DUE TO SU-E-MIZAJ BARID (COLD TEMPERAMENT) OR KHILT-E-BARID (COLD HUMOUR).

RECENT SCIENTIFIC STUDIES REVEALED THAT MANY SINGLE HERBAL DRUGS LIKE ASGANDH (Withania somnifera) AND TUKHM E KATAN (Linum usitatissimum) CONTAIN PHYTOESTROGENS WHICH HAS SHOWN THE GOOD RESULTS BY DECREASING THE SYMPTOMS OF POST-MENOPAUSAL SYNDROME.

A UNANI DRUG SATAVAR (Asparagus racemosus) IS SELECTED FOR STUDY IN PATIENTS OF POST MENOPAUSAL SYNDROME WHICH CONTAINS PHYTOESTROGENIC PROPERTIES ALONG WITH MUQAWWI-E-QALB (CARDIAC TONIC), MUHALLIL-E-WARM (ANTI-INFLAMMATORY), EMOLLIENT, COOLING, NERVINE TONIC, ANTI-DEPRESSANT, DIURETIC, REJUVENATING, CARMINATIVE, STOMACHIC, ANTISPASMODIC, ANTISEPTIC, ANTIOXIDANT AND HEPATOPROTECTIVE ACTIVITY.

 
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