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CTRI Number  CTRI/2019/12/022397 [Registered on: 17/12/2019] Trial Registered Prospectively
Last Modified On: 11/12/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   STUDY OF GOGHRIT PADABHYANGA IN THE MANAGEMENT OF NIDRANASH  
Scientific Title of Study   RANDOMIZED CONTROL STUDY OF GOGHRIT PADABHYANGA IN THE MANAGEMENT OF NIDRANASH WITH SPECIAL REFERENCE TO PRIMARY INSOMNIA”  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vd Alakananda Damodar Kulkarni  
Designation  Professor & HOD 
Affiliation  Hon. Shri Annasaheb Dange Ayurvedic Medical College, Ashta.  
Address  Hon. Shri Annasaheb Dange Ayurvedic Medical College, Ashta, Sangli.
Hon. Shri Annasaheb Dange Ayurvedic Medical College, Ashta, Sangli
Sangli
MAHARASHTRA
416301
India 
Phone  9689049577  
Fax    
Email  vdalaknandakulkarni@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sapna Dattatraya Morey  
Designation  PG Scholar  
Affiliation  Hon. Shri Annasaheb Dange Ayurvedic Medical College, Ashta.  
Address  Hon. Shri Annasaheb Dange Ayurvedic Medical College, Ashta, Sangli.
Hon. Shri Annasaheb Dange Ayurvedic Medical College, Ashta, Sangli

MAHARASHTRA
466116
India 
Phone  9028930563  
Fax    
Email  drsapnagawai@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vd Alakananda Damodar Kulkarni  
Designation  Professor & HOD 
Affiliation  Hon. Shri Annasaheb Dange Ayurvedic Medical College, Ashta.  
Address  Hon. Shri Annasaheb Dange Ayurvedic Medical College, Ashta, Sangli.
Hon. Shri Annasaheb Dange Ayurvedic Medical College, Ashta, Sangli
Sangli
MAHARASHTRA
416301
India 
Phone  9689049577  
Fax    
Email  vdalaknandakulkarni@gmail.com  
 
Source of Monetary or Material Support  
Hon. Shri Annasaheb Dange Ayurvedic Medical College and Dhanwantari pharmacy Ashta 
 
Primary Sponsor  
Name  Hon Shri Annasaheb Dange Ayurvedic Medical College Ashta 
Address  Hon. Shri Annasaheb Dange Ayurvedic Medical College, Ashta Tal Wales Distance Sangli 
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 
DrSapna Dattatraya Morey   Hon. Shri Annasaheb Dange Ayurvedic Medical College Dhanwantari Hospital Ashta   Hon. Shri Annasaheb Dange Ayurvedic Medical College, Ashta Tal Wales Dist Sangli
Sangli
MAHARASHTRA 		 9028930563

drsapnagawai@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: G998||Other specified disorders of nervous system in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Goghrit   Padabhyanga is carried out in supine, lateral and sitting position of the patient for 7 days early in the morning  
Comparator Agent  Til tail  Padabhyanga is carried out in supine, lateral and sitting position of the patient for 7 days early in the morning  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 The patients suffering from Nidranash like Shirogaurav, angamard, glani, Jrumbha, brama.
2 Age group 30-60 years
3 Sex-Male and female
4 Patients ready to trial procedure and ready to give informed consent
5 Difficulty in falling sleep or maintaining sleep or sleep of poor quality. 
 
ExclusionCriteria 
Details  1 Patient with any other mental disorder
2 Insomnia due to other condition like madatyaya, Abhighat and other systemic diseases were excluded.
3 Patient with any dermatological manifestation of feet.
4 Patient with feet injury.
5 Patient with diabetes, fever, cold and Indigestion. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study the effect of Goghrit Padabhyanga in management of Nidranash.
 		 18 months
 
 
Secondary Outcome  
Outcome  TimePoints 
1 To study the effect of Tiltailapadabhyanga in the management of Nidranash
2 To study the comparative efficacy of Goghrit and Tiltailapadabhyanga in management of Nidranash.
3 To evaluate the role of Padabhyanga in management of nidranash 		 60days 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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/ Phase 3 
Date of First Enrollment (India)   25/12/2019 
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)?  

Brief Summary   Clinical Research Project  named as "To study the effect  of Goghrit padabhyanga in the management of nidranash " will be conducted with support of Hon. Shri. Annasaheb Dange Ayurved Medical College, Ashta.
Today’s era is about Hurry worry so it is very common to people that they are suffering from nidranash  and to resolve this disease with the help of Ayurveda here making sincer efforts .
 
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