| CTRI Number |
CTRI/2025/03/082780 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Herbal drink for mental well-being in menopausal women: A study on Mandukaparnyadi Paniya |
|
Scientific Title of Study
|
A Clinical Study on Effectiveness of Mandukaparnyadi Paniya in Managing Psychological Symptoms During Menopausal Transition |
| 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 Namratha M V |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan |
| Address |
Department of Manovigyan Avum Manasa Roga Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla Hassan
Department of Manovigyan Avum Manasa Roga Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9482038520 |
| Fax |
|
| Email |
namrathamv47@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tapas Brata Tripathy |
| Designation |
Professor of department of Manovigyan avum Manasa roga |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan |
| Address |
Department of Manovigyan Avum Manasa Roga Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla Hassan
Department of Manovigyan Avum Manasa Roga Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9448705599 |
| Fax |
|
| Email |
tbtripathy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namratha M V |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan |
| Address |
Department of Manovigyan Avum Manasa Roga Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla Hassan
Department of Manovigyan Avum Manasa Roga Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9482038520 |
| Fax |
|
| Email |
namrathamv47@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, BM Road Thanniruhalla, Hassan, Karnataka, India phone number-08172256460, E-mail- sdmcah@gmail.com |
|
|
Primary Sponsor
|
| Name |
Dr Namratha M V |
| Address |
Department of Manovigyan Avum Manasa Roga Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla Hassan |
| 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 Namratha M V |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
Department of Manovigyan Avum Manasa Roga(opd-8)
Hassan
KARNATAKA |
09482038520
namrathamv47@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee sri Dharmasthala Manjunatheshwara college of ayurveda and hospital |
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: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Mandukaparnyadi paniya, Reference: NA, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 80(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1. Subjects under menopausal transition having irregular menstrual cycles.
2. Subjects who have not undergone Hormone Replacement Therapy.
3. Subjects who are willing to give consent for the study. |
|
| ExclusionCriteria |
| Details |
1. Patients with a history of mental or behavioral disorder.
2. Subjects with excessive bleeding in perimenopause due to artificial or premature
menopause.
3. Subjects who attained surgical menopause.
4. Patients diagnosed of major organic pathology of reproductive system like carcinoma,
fibroid, ovarian cyst etc. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in psychological symptoms such as Anxiety, Depression, Mood swings and sleep disturbances assessed using validated scales like the Menopausal rating scale(MRS) |
30days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in cognitive function, sleep quality, and overall quality of life |
30days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 physiological process denoted as Rajonivrutti Cessation of menstruation in Ayurveda Menopausal transition is a period which represents the passage from reproductive to non-reproductive life called as perimenopause This commonly occurs in women in their late 40s and early 50s psychological variations are a major concern during menopausal transition like trouble concentrating irritability fatigue depression anxiety sleep disturbances and poor memory when it causes discomfort either to mind or body it requires medical interference The hormonal fluctuations especially oestrogen that occurs during perimenopause can have a marked effect on psychological well-being Perimenopausal symptoms can have a significant impact on a woman s quality of life affecting her physical health emotional well-being and social functioning Symptoms such as hot flashes sleep disturbances and mood swings can interfere with daily activities work productivity and interpersonal relationships Prevalence of psychological symptoms is seen in 80% of women in perimenopausal period Some of the women may be asymptomatic or may have minimal symptoms or the symptoms may go unnoticed Hence there is an acute need to address the mental health status of this age group In contemporary system of medicine this condition is treated with Hormone replacement therapy HRT which is useful in treating vasomotor symptoms sleep disturbance and genitourinary symptoms and less efficient in treating psychological symptoms which is more prevalent in perimenopause Anxiolytics and Anti depressants can also be given but after withdrawal the symptoms reappear patient may become drug dependent Ayurveda literature also recognises the age group around 50 years as the period of Rajonivrutti Menopause During this period women is at the verge of middle age and there is gradual decline in all Dhatus bodily tissues eventually leading to Arthavakshaya cessation of menstruation This is correlated to perimenopausal stage An approach of combined medicinal herbs like shatavari mandukaparni guduchi having properties of Medhya nootropic Rasayana rejuvenation helps in balancing doshas and has phytoestrogen selective oestrogen receptor modulators SERM adaptogen anti-oxidant Thus the current study aimed at restoring mental health of this age group by administering a naturally available herbs as a medicine in the form of Paniya Kalpana which is convenient easy instant preparation in fast moving lifestyle |