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CTRI Number  CTRI/2024/12/078647 [Registered on: 27/12/2024] Trial Registered Prospectively
Last Modified On: 24/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A study to improve quality of life related to Hot flashes among menopausal women by integrating Ayurvedic Body Massage with pinda Taila and Yoga 
Scientific Title of Study   Combined effect of Pinda Taila Abhyanga and selected Yoga techniques in improving quality of life related to Hot flashes among Menopausal women 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arya M C 
Designation  PG Scholar, Department of Swasthavritta 
Affiliation  Government Ayurveda College, Tripunithura 
Address  Second year PG Scholar, Department of Swasthavritta, Government Ayurveda College, Tripunithura, Ernakulam

Ernakulam
KERALA
682301
India 
Phone  9497833096  
Fax    
Email  aryamc65@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vinuraj S 
Designation  Associate Professor, Department of Swasthavritta 
Affiliation  Government Ayurveda College, Tripunithura 
Address  Department of Swasthavritta, Government Ayurveda College, Tripunithura, Ernakulam

Ernakulam
KERALA
682301
India 
Phone  9447102737  
Fax    
Email  drvinurajs@gmail.com  
 
Details of Contact Person
Public Query  
Name  Arya M C 
Designation  PG Scholar, Department of Swasthavritta 
Affiliation  Government Ayurveda College, Tripunithura 
Address  Second year PG Scholar, Department of Swasthavritta, Government Ayurveda College, Tripunithura, Ernakulam

Ernakulam
KERALA
682301
India 
Phone  9497833096  
Fax    
Email  aryamc65@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda College and Hospital Tripunithura Ernakulam, Kerala- 682301 India 
 
Primary Sponsor  
Name  Government Ayurveda College, Tripunithura 
Address  Government Ayurveda College,Tripunithura, Puthiyakavu, Ernakulam Pincode:682301 
Type of Sponsor  Other [Government Ayurveda College, Tripunithura] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vinuraj S  Government Ayurveda College and Hospital, Tripunithura  Department Of Swasthavritta Government Ayurveda College and Hospital, Puthiyakaavu, Dhanwanthari Nagar, Tripunithura, 682301, Ernakulam
Ernakulam
KERALA 		 9447102737

drvinurajs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Committee for Ethics in Research, Government Ayurveda College Tripunithura, Ernakulam-682301  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N958||Other specified menopausal and perimenopausal disorders. Ayurveda Condition: USHMADHIKYAM (KEVALAPITTA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-aBya~ggaH, अभ्यंग  (Procedure Reference: Ashtanga Hridaya Sutrasthana, 2nd chapter Dinacharya, Procedure details: Participant should be seated in a chair with legs extended. The subject is advised to apply oil starting from leg, lower limbs, abdomen, chest, both upper limbs and on the neck, excluding face and head. Participant should take rest for 10 minutes. Bath in luke warm water with suitable medicated soap or snana choorna. Rasnadi choornam should be applied on head after snana.)
(1) Medicine Name: Pinda Tailam, Reference: Charaka Samhita Chikitsasthanam, Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 45 Days
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  a) Females who have achieved menopause.
b) Those who are willing for the study.
c) Females diagnosed having hot flashes as per Hot Flash Related Daily
Interference Scale (HFRDIS). 
 
ExclusionCriteria 
Details  a) Any known case of malignancy
b) Psychiatric disorders
c) Subjects undergoing hormone replacement therapy.
d) Subjects who have undergone hysterectomy 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the combined effect of Pinda Taila abhyanga and selected yoga techniques for 45 days by assessing the change in Hot Flash Related Daily
Interference Scale (HFRDIS).
 		 Treatment Period- 45 days
Assessment will be done on 0th and 45th day with Hot Flash Related Daily
Interference Scale (HFRDIS).
 
 
Secondary Outcome  
Outcome  TimePoints 
Change in Hot Flashes score  0th day and 45th day 
 
Target Sample Size   Total Sample Size="31"
Sample Size from India="31" 
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   N/A 
Date of First Enrollment (India)   10/01/2025 
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="0"
Months="1"
Days="15" 
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   A clinical trial with 31 subjects will be selected from OPD of Government Ayurveda College Tripunithura based on inclusion and exclusion criteria. Hot Flashes score will be assessed before intervention. The subject will be given ayurvedic management (Abhyanga with Pinda Taila and selected yoga techniques) for 45 days. Assessment will be done on 0th and 45th day. Data will be collected using a case proforma. The outcome of the study will be assessed processed and analysed statistically. 
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