| CTRI Number |
CTRI/2024/08/071979 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
12/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic management of symptoms before and during menopause |
|
Scientific Title of Study
|
A Comparative Clinical Study to evaluate the efficacy of Sapthavimshathi Guggulu and Soubhagya Vati after Virechana in Perimenopausal 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 Hasinabegum P |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda Medical College and Hospital Mysore |
| Address |
Post Graduate Department of Kayachikitsa Government Ayurveda Medical College and Hospital Vishweshwaraiah Circle Devraj Mohalla Mysore Karnataka 570001 India
Mysore KARNATAKA 570001 India |
| Phone |
9380327391 |
| Fax |
|
| Email |
hasina2410@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mythrey R C |
| Designation |
Professor and Head of the Department |
| Affiliation |
Government Ayurveda Medical College and Hospital Mysore |
| Address |
Post Graduate Department of Kayachikitsa Government Ayurveda Medical College and Hospital Mysore Vishweshwaraiah circle Devraj Mohalla Mysore Karnataka India 570001
Mysore KARNATAKA 570001 India |
| Phone |
8618570803 |
| Fax |
|
| Email |
mythreyrc@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Hasinabegum P |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda Medical College and Hospital Mysore |
| Address |
Post Graduate Department of Kayachikitsa Government Ayurveda Medical College and Hospital Vishweshwaraiah Circle Devraj Mohalla Mysore Karnataka 570001 India
Mysore KARNATAKA 570001 India |
| Phone |
9380327391 |
| Fax |
|
| Email |
hasina2410@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Medical College and Hospital Mysore Karnataka India 570001 |
|
|
Primary Sponsor
|
| Name |
Dr Hasinabegum P |
| Address |
Post Graduate Department of Kayachikitsa Government Ayurveda Medical College and Hospital Mysore Karnataka 570001 India |
| 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 Hasinabegum P |
Government Ayurveda Medical College and Hospital |
Room number 10 kayachikitsa OPD and IP Wards of Government Ayurveda Medical College and Hospital Mysore Karnataka 570001 India Mysore KARNATAKA |
9380327391
hasina2410@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Ayurveda Medical College Mysore |
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 | Drug | Classical | | (1) Medicine Name: SAPTHAVIMSHATI GUGGULU, Reference: Bhaishajya Ratnavali , Route: Oral, Dosage Form: Guggulu , Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Ushnajala), Additional Information: -(2) Medicine Name: SOUBHAGYA VATI, Reference: Bhaishajya Ratnavali Chapter 5, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Ushnajala), Additional Information: - | | 2 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: CHARAKA SAMHITA, Procedure details: Deepana Pachana with Chitrakadi Vati 250mg with luke warm water before food till the appearance of Nirama Lakshanas.
Shodhananga Snehapana will be administered in Aarohana Krama with Kalyanaka Ghritha from the day of Nirama Lakshanas till Samyak Snigdha Lakshanas are seen.
Sarvadaihika Abhyanga with Ksheerabala Taila followed by Nadi Sweda will be done for 3 days.
For the purpose of Virechana Trivrut Lehya will be administered after assessing the Koshta. Samsarjana Krama will be followed according to the type of Shuddhi
)
|
|
|
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Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Female subjects of age group 40 to 50 years
Subjects diagnosed based on diagnostic criteria |
|
| ExclusionCriteria |
| Details |
Subjects who have attained surgical menopause will be excluded
Subjects who are having uncontrolled diabetes and hypertension will be excluded
Subjects who are suffering from any other systemic disorders which interfere with the course of disease and treatment will be excluded
Subjects who are unfit for Virechana will be excluded |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessing relief in the symptoms of Perimenopausal syndrome like hot flushes,sweating,sleep problems,muscle and joint pain.
|
at baseline, after samsarjana krama(mid assessment) and 28th day after samsarjana krama(post assessment)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Sapthavimshathi Guggulu and Soubhagya Vati after Virechana in Perimenopausal syndrome by assessing relieving of symptoms through Green Climacteric Scale |
40th day |
| To compare the efficacy of Sapthavimshathi Guggulu and Soubhagya Vati after Virechana in Perimenopausal syndrome by assessing relieving of symptoms through Green Climacteric Scale |
After Virechna
After Samsarjana krama
After Completion of Intervention |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
20/08/2024 |
| 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="0" 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 means permanent cessation of menstruation at the end of reproductive life due to loss of ovarian follicular activity. Perimenopause is the part of the climacteric where the menstrual cycle is likely to be irregular It is associated with erratic fluctuation in reproductive hormone levels often leading to vasomotor symptoms change in mood or cognition and sexual dysfunction The prevalence of peri menopausal syndrome is 1.79% in 40 to 45 years 7.98% in 45-50 years In Ayurveda the time of Rajonivrutti is said to be 50 years The stage of Parihani (from 41 to 70 years) which comes under classification of age according to Sushrutha can be considered as perimenopausal age During this phase Sapthadhatu starts to debilitate This is the stepping stage from Madhyama Avastha to Vruddha Avastha This phase is the transition from Pitta Pradhana Avastha to the Vata Pradhana Avastha Both Shareerika and Maanasika doshas are affected producing symptoms like Alasya Shrama Dourbalya (physical exhaustion) Nidranasha (sleep problems) Klama The hormone replacement therapy is indicated in the menopausal women to overcome the short term and long term consequences of estrogen deficiency But estrogen hormone in long term usage causes endometrial and breast cancer coronary heart disease venous thromboembolic disease dementia and Alzheimer disease So non hormonal way of approach through ayurveda can be a priority Hence the study to evaluate the effect of Saptavimshati Guggulu and Soubhagya Vati after Virechana to manage both Shareerika and Manasika doshic vitiation in perimenopausal syndrome will be undertaken |