FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/08/073069 [Registered on: 29/08/2024] Trial Registered Prospectively
Last Modified On: 23/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Participants having Nidranash divided into two groups where one group get Til Taila Shirodhara and other get Til Taila Shirodhara with Jatamansi Tail Nasya as treatment for 7 days. 
Scientific Title of Study   A comparative clinical study of shirodhara with and without jatamansi tail nasya in nidranasha with special reference to primary insomnia  
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 Srujali Gat 
Designation  MD Scholar Panchakarma  
Affiliation  Sumatibhai Shah Ayurved Mahavidyalay Malwadi Hadapsar Pune 
Address  Sumatibhai Shah Ayurved Mahavidyalay Malwadi Hadapsar Pune OPD No. 6 Department of Panchakarma Sane Guruji Arogya Kendra Malwadi Hadapsar Pune Maharashtra 411028 India

Pune
MAHARASHTRA
411028
India 
Phone  9637164578  
Fax    
Email  srujaligat@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Maya Gokhale 
Designation  Head of Department of Panchakarma  
Affiliation  Sumatibhai Shah Ayurved Mahavidyalay Malwadi Hadapsar Pune  
Address  Sumatibhai Shah Ayurved Mahavidyalay Malwadi Hadapsar Pune OPD No. 6 Department of Panchakarma Sane Guruji Arogya Kendra Malwadi Hadapsar Pune Maharashtra 411028 India

Pune
MAHARASHTRA
411028
India 
Phone  9422323285  
Fax    
Email  drmayagokhale@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Srujali Gat  
Designation  MD Scholar Panchakarma  
Affiliation  Sumatibhai Shah Ayurved Mahavidyalay Malwadi Hadapsar Pune  
Address  Sumatibhai Shah Ayurved Mahavidyalay Malwadi Hadapsar Pune OPD No. 6 Department of Panchakarma Sane Guruji Arogya Kendra Malwadi Hadapsar Pune Maharashtra 411028 India

Pune
MAHARASHTRA
411028
India 
Phone  9637164578  
Fax    
Email  srujaligat@gmail.com  
 
Source of Monetary or Material Support  
Department of Panchakarma Sane Guruji Arogya Kendra Malwadi Hadapsar Pune 411028 
 
Primary Sponsor  
Name  SANE GURUJI AROGYA KENDRA  
Address  SANE GURUJI AROGYA KENDRA MALWADI HADAPSAR PUNE 411028 
Type of Sponsor  Research institution and hospital 
 
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 Srujali Satish Gat  Sane Guruji Arogya Kendra  Opd No.6 Department of Panchakarma Sane Guruji Arogya Kendra Malwadi Hadapsar Pune Maharashtra
Pune
MAHARASHTRA 		 9637164578

srujaligat@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MAM SSAM And Sane Guruji Arogya Kendra Institution Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F489||Nonpsychotic mental disorder, unspecified. Ayurveda Condition: NIDRANASAH/ASVAPNAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-mUrdhatailam/ Sirastailam, मूर्धतैलम्/ शिरस्तैलम् (Procedure Reference: Sushrut Samhita, Procedure details: Shirodhara is a word comprising of 2 terms, Shiro meaning head, Dhara meaning dripping of medicated oil. The procedure in which dripping of medicated oil is carried over the head region for about 30 minutes for once a day for 7 days.)
(1) Medicine Name: Til Taila, Reference: Bhavprakash Nighantu Haritakyadi Varga , Route: Topical, Dosage Form: Taila, Dose: 800(ml), Frequency: od, Duration: 7 Days
2Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Ashtang Sangraha, Procedure details: Administration of drug/medicated Sneha by nasal cavity is called as Nasya. Here 8 Bindu of Jatamansi Tail is used as medicated Nasya Sneha in each nostril as Marsha Nasya once a day for 7 days.)
(1) Medicine Name: Jatamansi taila, Reference: Dravyaguna Vigyan Jatamansi, Route: Nasal, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients showing maximum classical sign and symptoms of Nidranasha. Gender- Both male and female patients included. Age group: 30-60 year is included. Sign and symptoms of Stressful life situation causing insomnia (Primary Insomnia). Nasya Arha. Shirodhara Arha. Patient having Sleep Efficiency Index (SEI) below 80%  
 
ExclusionCriteria 
Details  Known case of systemic diseases which interfere the treatment. Chronic alcoholism, drug dependent, chronic mental disorders and mental diseases.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the add-on effect of Jatamansi Tail Nasya along with Shirodhara by Til Tail in Nidranasha with special reference to primary insomnia.  TREATMENT WILL BE GIVEN FOR 7 DAYS.PATIENTS WILL BE ASSESSED ON 0TH,7TH AND FOLLOW UP ON 15TH DAY. 
 
Secondary Outcome  
Outcome  TimePoints 
To study the effect of Til Tail Shirodhara in Nidranasha with special reference to primary insomnia.  PATIENTS WILL BE ASSESSED ON 0TH,7TH AND FOLLOW UP ON 15TH DAY. 
 
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   N/A 
Date of First Enrollment (India)   10/09/2024 
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="6"
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   This is a comparative clinical study where in this study add on effect of Jatamasi Tail Nasya with common treatment of Til Tail Shirodhara in Nidranasha (Primary Insomnia) for 7 days will be studied. One group of Nidranasha patients will be treated with Shirodhara of Tila Tail with Jatamansi Tail Nasya. Second group of Nidranasha will be treated with Shirodhara of Tila Tail for 7 days. Observations will be drawn from the outcome of treatment. 
Close