| CTRI Number |
CTRI/2026/03/106678 [Registered on: 20/03/2026] Trial Registered Prospectively |
| Last Modified On: |
20/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Study on the Effect of Sariba Useeradi Herbal drink and Yoga practices in reducing Menopause symptoms in women aged 45 to 60 years |
|
Scientific Title of Study
|
Effect of Sariba Useeradi Herbal Drink and Selected Yoga Techniques in Postmenopausal Syndrome A Non Randomized Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chris Merin Joseph |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda College Thiruvananthapuram Kerala India |
| Address |
Department of Swasthavritta
Government Ayurveda College
Thiruvananthapuram
Kerala
India
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9400892599 |
| Fax |
|
| Email |
e.j.chrismerin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudha S |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda College Thiruvananthapuram Kerala India |
| Address |
Department of Swasthavritta
Government Ayurveda College
Thiruvananthapuram
Kerala
India
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9048927865 |
| Fax |
|
| Email |
drsudhasd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chris Merin Joseph |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda College Thiruvananthapuram Kerala India |
| Address |
Department of Swasthavritta
Government Ayurveda College
Thiruvananthapuram
Kerala
India
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9400892599 |
| Fax |
|
| Email |
e.j.chrismerin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College
Thiruvananthapuram
Kerala
India
Pin 695001 |
|
|
Primary Sponsor
|
| Name |
Chris Merin Joseph |
| Address |
PG Scholar
Department of Swasthavritta
Government Ayurveda College
Thiruvananthapuram
Kerala India 695001 |
| 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 |
| Dr Chris Merin Joseph |
Government Ayurveda Panchakarma Hospital Thiruvananthapuram |
OP Number 2
Department of Swasthavritta
Government Ayurveda Panchakarma Hospital Thiruvananthapuram
Thiruvananthapuram
KERALA |
9400892599
e.j.chrismerin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GOVERNMENT AYURVEDA COLLEGE THIRUVANANTHAPURAM KERALA |
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: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sariba Useeradi Herbal Drink, Reference: Ashtanga Hrudayam Sootrasthanam Chapter 15 Verse 11, Route: Oral, Dosage Form: Panak/ Sharbat, Dose: 200(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: NIL, Ritucarya: NIL, Acara Rasayana:NIL, Other:YOGA
1 Prayer loosening exercises 10 minutes
2 Tadasana duration 3 minutes frequency 3
3 Padahasthasana duration 3 minutes frequency 3
Relaxation Savasana
4 Paschimottanasana duration 3 minutes frequency 3
5 Ardhamerudandasan duration 3 minutes frequency 3
6 Relaxation Makarasana
7 Sooryanamskara duration 15 minutes frequency 5
Relaxation Savasana 3 minutes
8 Pranayama duration 3 minutes frequency 3
, Pathya/Apathya:yes, Pathya:Ksheera Mudga Dadima Amalaka Sali Vyayama , Apathya:Intake of foods which are excessively katu amla and ushna PickleFatty calorie rich food Friedfood Ativyayama Vegadharana Sedentary life
|
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Participants of age group 45-60 years who falls under STRAW Stage +1 and has a score of 21 out of 63 in Greene Climacteric Scale. |
|
| ExclusionCriteria |
| Details |
Participants who are undergoing Hormone Replacement Therapy or any other medication for managing Menopausal symptoms.
Diagnosed case of malignancies, uncontrolled diabetes and hypertension.
Diagnosed case of psychiatric illness.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in the following symptoms
1.Heart beating quickly or slowly
2.Feeling tense or nervous
3.Difficulty in sleeping
4.Excitable
5.Attacks of panics
6.Difficulty in concentrating
7.Feeling tired or lacking in energy
8.Loss of interest in most of things
9.Feeling unhappy or depressed
10.Crying spells
11.Irritability
12.Feeling dizzy or faint
13.Pressure or tightness on head or body
14.Parts of body feel numb or tingling
15.Headaches
16.Muscles and joint pains
17.Loss of feeling in hands or feet
18.Breathing difficulties
19.Hot flushes
20.Sweating at night
21.Loss of interest in sex
assessed by Greene Climacteric Scale |
0th day,46th day and 61st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the changes in BMI, Lipid profile and FBS |
0th day,46th day and 61st day |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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 4 |
|
Date of First Enrollment (India)
|
06/04/2026 |
| 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="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
|
Menopause is a natural phase in a womans life characterized by the permanent cessation of menstruation due to hormonal changes. Many women experience symptoms such as hot flushes mood swings sleep disturbances and psychological discomfort which can significantly affect their quality of life. Although hormone therapy is commonly used to manage these symptoms long term use may increase the risk of conditions such as cardiovascular disease and certain cancers. This study aims to evaluate the effect of Sariba Useeradi herbal drink combined with selected yoga techniques in managing postmenopausal syndrome. The study will be conducted as a non randomized clinical trial at Government Ayurveda Panchakarma Hospital Thiruvananthapuram including 56 postmenopausal women aged 45 to 60 years. Participants will be divided into two groups one group will receive Sariba Useeradi herbal drink along with yoga while the other group will practice only yoga for 45 days.The Greene Climacteric Scale will be used to assess menopausal symptoms on zeroth day forty sixth day and sixty first day. The results will help to understand whether addition of an Sariba Useeradi herbal drink can improve the post menopausal symptoms. |