| 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
|
|
|
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
|
|
|
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 INCONTINENCE, URGENCY 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. |