| CTRI Number |
CTRI/2026/03/106999 [Registered on: 27/03/2026] Trial Registered Prospectively |
| Last Modified On: |
19/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
AN INTERVENTION TO EVALUATE THE EFFICACY OF AMALAKI RASAYANA IN THE MANAGEMENT OF MENOPAUSAL SYNDROME OF PARTICIPANTS |
|
Scientific Title of Study
|
AN OPEN LABEL SINGLE ARM CLINICAL STUDY TO EVALUATE THE EFFICACY OF AMALAKI RASAYANA IN THE MANAGEMENT OF MENOPAUSAL SYNDROME |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR PRIYANKA |
| Designation |
PHD SCHOLAR |
| Affiliation |
INSTITUTE FOR AYURVEDA STUDIES AND RESEARCH |
| Address |
OPD NO 15 DEPARTMENT OF STREE ROGA-PRASUTI TANTRA INSTITUTE FOR AYURVEDA STUDIES AND RESEARCH UMRI ROAD SECTOR 8 KURUKSHETRA
Kurukshetra
HARYANA
136118
India |
| Phone |
9416828927 |
| Fax |
|
| Email |
drvana88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR JITESH KUMAR PANDA |
| Designation |
CHAIRPERSON |
| Affiliation |
INSTITUTE FOR AYURVEDA STUDIES AND RESEARCH |
| Address |
ROOM NO 112 DEPT OF STREE ROGA-PRASUTI TANTRA INSTITUTE FOR AYURVEDA STUDIES AND RESEARCH UMRI ROAD SECTOR 8 KURUKSHETRA
Kurukshetra
HARYANA
136118
India |
| Phone |
9896033056 |
| Fax |
|
| Email |
drjk67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PRIYANKA |
| Designation |
PHD SCHOLAR |
| Affiliation |
INSTITUTE FOR AYURVEDA STUDIES AND RESEARCH |
| Address |
OPD NO 15 DEPARTMENT OF STREE ROGA-PRASUTI TANTRA INSTITUTE FOR AYURVEDA STUDIES AND RESEARCH UMRI ROAD SECTOR 8 KURUKSHETRA
Kurukshetra
HARYANA
136118
India |
| Phone |
9416828927 |
| Fax |
|
| Email |
drvana88@gmail.com |
|
|
Source of Monetary or Material Support
|
| INSTITUTE FOR AYURVEDA STUDIES AND RESEARCH SHRI KRISHNA AYUSH UNIVERSITY SECTOR 8 UMRI ROAD KURUKSHETRA |
|
|
Primary Sponsor
|
| Name |
INSTITUTE FOR AYURVEDA STUDIES AND RESEARCH |
| Address |
SECTOR 8 UMRI ROAD KURUKSHETRA |
| 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 |
| DR PRIYANKA |
INSTITUTE FOR AYURVEDA STUDIES AND RESEARCH |
OPD NO 15 DEPARTMENT OF STREE ROGA-PRASUTI TANTRA SECTOR 8 UMRI ROAD KURUKSHETRA HARYANA
Kurukshetra
HARYANA |
9416828927
drvana88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC SKAU KURUKSHETRA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N951||Menopausal and female climactericstates. Ayurveda Condition: RAJONASAH (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: AMALAKI RASAYANA , Reference: BHAISHAJYA RATNAVALI CHAPTER SEVENTY THREE SHLOKA TWENTY-FIVE , Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: WATER ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
AMENORRHEA MORE OR OF TWELVE MONTHS
SERUM ESTRADIOL LEVEL LESS THAN TWENTY pg PER ml
PATIENTS WITH SIGNS AND SYMPTOMS OF MENOPAUSE WITH SIGNED INFORMED CONSENT |
|
| ExclusionCriteria |
| Details |
PATIENT NOT WILLING TO PARTICIPATE IN CLINICAL TRIAL
PATIENTS WITH DOCUMENTED HISTORY OF MALIGNANCY DIABETES HTN OR ANY OTHER MAJOR SYMPTOMATIC ILLNESS
PATIENTS ON PROLONGED MEDICATIONS ON CORTICOSTEROIDS ANTIDEPRESSANT TUBERCULAR DRUGS ETC
PATIENT HAVING AGE LESS THAN FORTY YEARS AND MORE THAN FIFTY FIVE YEARS
PATIENT WITH ANY HISORY OF ORGANIC PELVIC LESION LIKE FIBROID UTERUS PELVIC INFLAMMATORY DISEASE
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| WILL ASSESS IMPROVEMENT IN SYMPTOMS OF MENOPAUSAL SYNDROME AFTER INTERVENTION KF AMALAKI RASAYANA |
DAY 1 DAY 15 DAY 30 DAY 45 DAY 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| CHANGES WILL BE OBSERVE IN SERUM ESTRADIOL LEVEL AND SERUM CALCIUM LEVEL |
DAY 1 DAY 45 |
|
|
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)
|
03/06/2026 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
MENOPAUSE DEFINES A PERMANENT CESSATION OF MENSTRUATION AT THE END OF REPRODUCTIVE LIFE DUE TO LOSS OF OVARIAN FOLLICULAR ACTIVITY AYURVEDIC LITERATURE HAS MENTIONED MENOPAUSE AS NATURAL PHENOMENON IN LIFE OF WOMEN AS RAJONIVRITI AND DEPICTED AS JARAPAKRA AVASTHATHE DIAGNOSIS OF MENOPAUSE IS NOT MADE UNTIL THE INDIVIDUAL HAS HAD TWELVE MONTHS OF AMENORRHEA THIS OPEN LABEL SINGLE ARM CLINICAL STUDY AIMS TO EVALUATE THE EFFICACY OF AMALAKI RASAYANA IN MANAGEMENT OF MENOPAUSAL SYNDROME A TOTAL OF HUNDRED PATIENTS WITH MENOPAUSAL SYMPTOMS WILL BE ENROLLED AND TREATED WITH AMALAKI RASAYANA TEN GRAM BD FOR FORTY FIVE DAYS THE EFFECT OF INTERVENTION WILL BE ASSESSED USING SIGNS AND SYMPTOMS OF MENOPAUSAL SYNDROME AND BIOCHEMICAL PARAMETERS SUCH AS SERUM ESTRADIOL AND SERUM CALCIUM THE STUDY INTENDS OF AMALAKI RASAYANA IN REDUCING MENOPAUSAL SYMPTOMS AND IMPROVING QUALITY OF LIFE |