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CTRI Number  CTRI/2024/07/070654 [Registered on: 15/07/2024] Trial Registered Prospectively
Last Modified On: 11/07/2024
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   A study to evaluate the effect of nasal administration of Brihat Shatavari Ghrita in the management of Premenstrual syndrome 
Scientific Title of Study   A controlled clinical study to evaluate the add on effect of Brihat Shatavari Ghrita as Prathimarsha nasya in the management of Premenstrual syndrome vis-a-vis Pittavruta vyana vata 
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 Hitha M K 
Designation  PG Scholar, Department of Swasthavritta and Yoga 
Affiliation  Government Ayurveda Medical College and Hospital, Mysuru 
Address  Government Ayurveda Medical College and Hospital, Vishweshwaraiah circle,Devaraj mohalla Mysuru, Karnataka, India - 570001

Mysore
KARNATAKA
570001
India 
Phone  9071987170  
Fax    
Email  hithamadthila7256@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sudheendra G Nawale 
Designation  Professor, Department of Swasthavritta and Yoga 
Affiliation  Government Ayurveda Medical College and Hospital, Mysuru 
Address  OPD No.12 Department of Swasthavritta and Yoga Government Ayurveda Medical College and Hospital Vishweshwaraiah circle Devaraj mohalla Mysuru Karnataka India - 570001

Mysore
KARNATAKA
570001
India 
Phone  9341061821  
Fax    
Email  sudhi130207t@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Hitha M K 
Designation  PG scholar, Department of Swasthavritta and Yoga 
Affiliation  Government Ayurveda Medical College and Hospital, Mysuru 
Address  OPD No.12 Department of Swasthavritta and Yoga Government Ayurveda Medical College and Hospital Vishweshwaraiah circle Devaraj mohalla Mysuru Karnataka India - 570001

Mysore
KARNATAKA
570001
India 
Phone  09071987170  
Fax    
Email  hithamadthila7256@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda Medical College and Hospital Mysore 
 
Primary Sponsor  
Name  Dr Hitha M K 
Address  Government Ayurveda Medical College and Hospital Vishweshwaraiah circle Devaraj mohalla Mysuru Karnataka India 570001 
Type of Sponsor  Other [self] 
 
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 Hitha M K  Government Ayurveda Medical College and Hospital Mysuru  OPD No. 12 Department of Swasthavritta and Yoga Government Ayurveda Medical College and Hospital Vishweshwaraiah circle Devaraj mohalla Mysuru Karnataka India 570001
Mysore
KARNATAKA 		 9071987170

hithamadthila7256@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Government Ayurveda Medical College and Hospital Mysuru  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E319||Polyglandular dysfunction, unspecified. Ayurveda Condition: PITTAVRUTAVYANAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmLifestyle--Dinacarya: Prathimarsha Nasya, Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:no, Pathya:, Apathya:
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  30.00 Year(s)
Gender  Female 
Details  Subjects diagnosed based on diagnostic criteria (Premenstrual Syndrome Scale)
Subjects having regular menstrual cycle (21-35 days) 
 
ExclusionCriteria 
Details  Any diagnosed clinical condition that interferes with the clinical trial
Subjects under hormonal treatment 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the add on effect of Brihat Shatavari Ghrita as Prathimarsha Nasya over Punarnavadi Kashaya and Ashwagandha Churna in Premenstrual Syndrome   21-35 days (after 1st menstrual cycle) 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the combined effect of Brihat Shatavari Ghrita as Prathimarsha Nasya over Punarnavadi Kashaya and Ashwagandha Churna in Premenstrual Syndrome   21-35 days (after 1st menstrual cycle) 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   22/07/2024 
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 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  

Premenstrual syndrome (PMS) refers to a complex of cyclical and recurrent physical emotional and behavioral symptoms that occurs specifically in the luteal phase and remain for minimum three consecutive menstrual cycles

In India a range of 14.3% to 74.4% is the reported prevalence estimate of PMS
In Ayurveda PMS can be related to Pittavrita vyana vata  which is an Avaranajanya Vyadhi. Rituvyatheetha kala is compared mainly with luteal phase there is Pittakopavastha and Vata sanchayavastha. With excessive intake of Pittakara nidana in Rituvyatheethakala  Sanchita vata specifically Vyana vata gets Avrita with Kupita pitta and manifested in the form of Sarvanga daha Klama Santapa etc

As per contemporary system of medicine management available for this condition is Antidepressants (SSRIs) NSAIDs diuretics and hormonal contraceptives. These can cause nausea sleep problems drowsiness etc.

The disease PMS can be managed and treated on the line of Pittavrita vyana vata so as to provide relief from its deleterious effects and improve ones family and social life.

In classics the treatment for Pittavrita vyana vata includes Jeevaneeya gana drugs

Brihat Shatavari Ghrita contains Jeevaneeya gana drugs which is Balya  Agnivardhaka does Shamana of Angadaha Raktapitta Vatarakta Paithika Jwara. Ghrita is Vatapitta shamaka. Shatavari has Rasayana effect Medhya Tridoshashamaka Agnibalavardhaka which counteract the PMS vis a vis Pittavrita vyana vata.

Pratimarsha nasya is one among Dinacharya procedures which is helpful in promotion of health. It shows action on regulation of endocrine system and nervous system functions. As PMS is a physiological condition Brihat Shatavari Ghrita can be given as Prathimarsha nasya for promotion of health.

Therefore considering the above information this study is planned to evaluate the effect of Brihat Shatavari Ghrita as Pratimarsha nasya in PMS.












 
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