| CTRI Number |
CTRI/2024/07/070126 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
03/07/2024 |
| 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
|
Evaluation of effect of Bhringarajadi Churna in Perimenopausal Syndrome over Yoga Techniques |
|
Scientific Title of Study
|
A controlled clinical study to evaluate the add on rasayana effect of bhringarajadi churna in perimenopausal syndrome over selected yoga techniques |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rema Madhu |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVERNMENT AYURVEDA MEDICAL COLLEGE |
| Address |
Room number 2, department of swasthavritha, second floor, charaka government post graduate centre, brindavan extension, Mysuru
Mysore
KARNATAKA
570020
India |
| Phone |
9400607807 |
| Fax |
|
| Email |
drremamadhu92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudheendra B Nawale |
| Designation |
PROFESSOR |
| Affiliation |
GOVERNMENT AYURVEDA MEDICAL COLLEGE |
| Address |
Room no. 12, ground floor, opd block,government ayurveda medical college, viswesvaraiah circle, devaraja mohalla, mandi mohalla, mysuru
KARNATAKA
570001
India |
| Phone |
9400607807 |
| Fax |
|
| Email |
sudhi130207t@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rema Madhu |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVERNMENT AYURVEDA MEDICAL COLLEGE |
| Address |
Room no. 12, ground floor, opd block,Government ayurveda medical college, Viswesvaraiah circle, Devaraja mohalla, Mandi mohalla, Mysuru
KARNATAKA
570001
India |
| Phone |
9400607807 |
| Fax |
|
| Email |
drremamadhu92@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Medical College, Mysuru |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NI |
| Type of Sponsor |
Other [NIL] |
|
|
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 REMA MADHU |
GOVERNMENT AYURVEDA MEDICAL COLLEGE AND HOSPITAL |
Room no. 12, ground floor, opd block,Government ayurveda medical college, Viswesvaraiah circle, Devaraja mohalla, Mandi mohalla, Mysuru
Mysore
KARNATAKA |
9400607807
drremamadhu92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government ayurveda medical college institutional ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N959||Unspecified menopausal and perimenopausal disorder. Ayurveda Condition: VARDHAKYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Yoga | Parvatasana vrikshasana baddhakonasana pavanamuktasana adhomukhashwanasana nadi shuddhi pranayama sheetali pranayama sheetakari pranayama bhramari pranayama, once a day, for 30 days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: BHRINGARAJADI CHURNAM, Reference: BHAISHAJYA RATNAVALI, RASAYANA PRAKARANA, SHLOKA 128, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: USHNA JALA), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1.Subjects diagnosed based on Menopausal Rating Scale
2.Not undergone hormonal therapy
3.Subjects under controlled hypertension and Diabetes Mellitus |
|
| ExclusionCriteria |
| Details |
1.Women post hyterectomy
2.Women Suffering from any other systemic disorders which interfere with cause of disease and treatment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in quality of life of women in peimenopausal age |
61 DAY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assesment of Quality of life under physical psychological parameters |
90th day |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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 3 |
|
Date of First Enrollment (India)
|
02/08/2024 |
| 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="5"
Days="2" |
|
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
|
The perimenopause is the transition period from normal ovulatory cycles to menopause. It is associated with erratic fluctuations in reproductive hormone levels, often leading to irregular menstrual cycles, vasomotor symptoms, changes in mood or cognition, and sexual dysfunction.
The prevalence of perimenopause is 1.79% in 40-45 years and 7.98% in 45-50years.
In ayurveda the menopause is termed as Rajonivrutti. The age of Rajonivrutti is mentioned as 50 years. The classification of age according to sushruta samhitha, has 4 1 stages; vridhi (upto20) youvana (upto30), sampurana (upto 30) and parihani (upto 70).
The Initial stages of Parihani can be considered as perimenopausal age. That is transition from pitta pradhana avasta to vata pradhana avasta Jara is vata pradhana avastha In this transition due to vata vridhi shareerika and manasika bhavas are affected.
As per contemporary system of medicine, management available for this condition is Hormone Replacement Therapy (HRT) to overcome short term and long-term estrogen imbalance. Synthetic Estrogen hormone on long term usage causes endometrial and breast cancer, coronary heart disease, various thromboembolic disease, dementia and alzheimer’s disease.
As hormonal therapy is having its limitation, non-hormonal way of approach through ayurveda is necessary. Menopausal transition being Kata predominant, the line of treatment adopted here is Brumhana, Bhringarajadi choorna is a combination of bhringaraja, amalaki and tila which have Balya, Hridhya, Dahaprashamana, Brimhana and Rasayana guna This will be beneficial for vatashamana and dhatu poshana, having added effect on manasika bhavas. Yogasanaas and pranayama are recognized as techniques that can improve muscle strength, flexibility, blood circulation and oxygen uptake as well as hormonal function. On the other hand, another review focusing specifically on efficacy of yoga in menopausal symptom reduction concluded that there is sufficient evidence to recommend yoga as an intervention. Considering all this the study is being planned |