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CTRI Number  CTRI/2021/05/033698 [Registered on: 20/05/2021] Trial Registered Prospectively
Last Modified On: 17/05/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device
Ayurveda
Diagnostic
Preventive 
Study Design  Other 
Public Title of Study   A randomized clinical control study of mustha-amalaki siddha takradhara in management of rajoniwritti with special reference to menopausal stress 
Scientific Title of Study   A randomized clinical control study of mustha–amalaki siddha takradhara in management of rajonivritti with special reference to stress 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Alakananda Kulkarni 
Designation  Md kaychikista 
Affiliation  annasaheb dange ayurved medical college ashta  
Address  ADAMC 772 Gaonbhag Sangli
annasaheb dange ayurved medical college and post graduation research training center ashta dist sangli
Sangli
MAHARASHTRA
416416
India 
Phone  9860359489  
Fax    
Email  vdalaknandakulkarni@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Alakananda Kulkarni 
Designation  Md kaychikista 
Affiliation  annasaheb dange ayurved medical college ashta  
Address  ADAMC 772 Gaonbhag Sangli
annasaheb dange ayurved medical college and post graduation research training center ashta dist sangli
Sangli
MAHARASHTRA
416416
India 
Phone  9860359489  
Fax    
Email  vdalaknandakulkarni@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Alakananda Kulkarni 
Designation  Md kaychikista 
Affiliation  annasaheb dange ayurved medical college ashta  
Address  ADAMC 772 Gaonbhag Sangli
annasaheb dange ayurved medical college and post graduation research training center ashta dist sangli
Sangli
MAHARASHTRA
416416
India 
Phone  9860359489  
Fax    
Email  vdalaknandakulkarni@gmail.com  
 
Source of Monetary or Material Support  
Hon Shree Annasaheb dange ayurved medical college ashta dist sangli tal Walwa 416301 
 
Primary Sponsor  
Name  Hon Shree Annasaheb Dange yurved medical college ashta 
Address  Hon Shree Annasaheb Dange ayurved medical college and post graduation research training center ashta 
Type of Sponsor  Private medical college 
 
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 Sonal Bhagwan Pandav  Hon shri annasaheb dange ayurved medical college ashta  Hon shri annasaheb dange ayurved medical college and post graduation research training center ashta dist sangli Sangli MAHARASHTRA
Sangli
MAHARASHTRA 		 7709692573

sonalpandav27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F411||Generalized anxiety disorder. Ayurveda Condition: Rajonivritti ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Jatamansi phant shirodhara  Jatamansi phant shirodhara 7 days for 30 mins 
Intervention  Mustha–amalaki siddha takradhara in mangement of rajonivritti with special reference to stress  Mustha-amalaki siddha takradhara 7 days for 30 mins 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  Patient between age 35 to 55 years of females shows classical sings and symptoms of Rajonivritti stress patient having stress hot flushes, anxiety, vaginal dryness, loss of libido, insomnia, mood swings. 
 
ExclusionCriteria 
Details  Patients with the history of systemic disorders, infections & under anti psychotic drugs
Patients on HRT (Harmone Replacement Therapy)
Crippling conditions like malignancy chronic disorders, R. A., Coronary artery disease etc. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study the the efficacy of Mustha – Amalaki Siddha Takradhara In Mangement Of Rajonivritti With Special Reference To Stress by Stress scale   18 months
Lakshana-
1 Hot Flushes
2 Anxiety
4 Vaginal Dryness
5 Loss of libido
6 Insomnia
7 Mood-swing
8 Sleeplessnes
9 Headache
 
 
Secondary Outcome  
Outcome  TimePoints 
To study the mode of action of Mustha – Amalaki Siddha Takradhara By using siddha takradhara for patients and see the results by analysis of mood,sleep , behaviour changes of patients etc.  7 days Lakshana
1 Hot Flushes
2 Anxiety
4 Vaginal Dryness
5 Loss of libido
6 Insomnia
7 Mood-swing
8 Sleeplessness
9. Headache
Discussion
 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 
Date of First Enrollment (India)   27/05/2021 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Clinical research project named as a randomized clinical control study of mustha-amalaki sIddha takradhara in management of rajonivrtti with special reference to stress  will be conducted with support of Hon shri annasaheb dange ayurved medical college ashta
 
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