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CTRI Number  CTRI/2025/01/079537 [Registered on: 27/01/2025] Trial Registered Prospectively
Last Modified On: 26/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Tagar Kwatha Shirodhara is better in Insomnia 
Scientific Title of Study   A Randomized controlled clinical trial of Tagar kwatha Shirodhara in management of Anidra 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  VdPranali Narendra Netam 
Designation  PG Scholar 
Affiliation  PDEAS COLLEGE OF AYURVED AND RESEARCH CENTRE SECTOR NO 25 NIGADI PUNE 411044 
Address  PDEA COLLEGE OF AYURVED AND RESEARCH CENTRE THIRD FLOOR PANCHKARMA DEPARTMENT OPD NUMBER 216 SECTOR NO 25 NIGADI PUNE MAHARASHTRA PUNE 411044 MAHARASHTRA 411044 INDIA Pune MAHARASHTRA 411044 India
PDEA COLLEGE OF AYURVED AND RESEARCH CENTRE THIRD FLOOR PANCHKARMA DEPARTMENT OPD NUMBER 216 SECTOR NO 25 NIGADI PUNE MAHARASHTRA PUNE 411044
Pune
MAHARASHTRA
411044
India 
Phone  7820934895  
Fax    
Email  pranalinetam96@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  VdPRIYA BANGAR 
Designation  ASSISTANT PROFFESOR 
Affiliation  PDEAS COLLEGE OF AYURVED AND RESEARCH CENTRE SECTOR NO 25 NIGADI PUNE 411044 
Address  PDEA COLLEGE OF AYURVED AND RESEARCH CENTRE THIRD FLOOR PANCHKARMA DEPARTMENT OPD NUMBER 216 SECTOR NO 25 NIGADI PUNE MAHARASHTRA PUNE 411044 MAHARASHTRA 411044 INDIA Pune MAHARASHTRA 411044 India
PDEA COLLEGE OF AYURVED AND RESEARCH CENTRE THIRD FLOOR PANCHKARMA DEPARTMENT OPD NUMBER 216 SECTOR NO 25 NIGADI PUNE MAHARASHTRA PUNE 411044 MAHARASHTRA 411044 INDIA Pune MAHARASHTRA 411044 India
Pune
MAHARASHTRA
411044
India 
Phone  9881727311  
Fax    
Email  drpriyabangar@gmail.com  
 
Details of Contact Person
Public Query  
Name  VdPranali Narendra Netam 
Designation  PG Scholar 
Affiliation  PDEAS COLLEGE OF AYURVED AND RESEARCH CENTRE SECTOR NO 25 NIGADI PUNE 411044 
Address  PDEA COLLEGE OF AYURVED AND RESEARCH CENTRE THIRD FLOOR PANCHKARMA DEPARTMENT SECTOR NO 25 NIGADI PUNE MAHARASHTRA PUNE 411044 MAHARASHTRA 411044 INDIA Pune MAHARASHTRA 411044 India

Pune
MAHARASHTRA
411044
India 
Phone  7820934895  
Fax    
Email  pranalinetam96@gmail.com  
 
Source of Monetary or Material Support  
PDEAS COLLEGE OF AYURVED AND RESEARCH CENTRE SECTOR NO 25 NIGADI PUNE 411044 
 
Primary Sponsor  
Name  PDEAS COLLEGE OF AYURVED AND RESEARCH CENTRE NIGADI PUNE 411044 
Address  PDEAS COLLEGE OF AYURVED AND RESEARCH CENTRE SECTOR 25 NIGADI PUNE 411044 
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 
VdPranali Narendra Netam  Ayurved Rugnalay And Sterling Multispeciality Hospital Nigadi Pradhikaran Pune   Third Floor Panchkarma Department OPD no.216 Nigadi Pradhikaran Pune Maharashtra 411044 Pune MAHARASHTRA
Pune
MAHARASHTRA 		 07820934895

pranalinetam96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PDEA COLLEGE Institutional Ethical 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-SiraHsekaH, शिरःसेकः (Procedure Reference: Dharakalpa, Procedure details: Ingredients - JATAMANSI BHARAD Route - Topical Dosage - Kwatha/Kashya Dose - 2000 ml Frequency - OD Duration - 30 mins for 7 days)
2Intervention ArmProcedure-SiraHsekaH, शिरःसेकः (Procedure Reference: DHARAKALPA, Procedure details: Ingredients - TAGAR BHARAD Route - Topical Dosage - Kwatha/Kashya Dose - 2000 ml Frequency - OD Duration - 30 mins for 7 days)
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients having symptoms like Tandra, Manadaurbalya, Shirogauravta and other insomnia symptoms
Patients suffering from Anidra for one month or more
Patients fit for Shirodhara Karma  
 
ExclusionCriteria 
Details  Patients below 16 years of age and above 60 years of age

Patients suffering with any other major illness or Atinidra

Garbhini and Lactating Mothers

Patients having Hypersensitivity reactions for drugs Tagar and Jatamansi

Malignancy 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To determine efficacy of Tagar kwatha Shirodhara as compared to Jatamansi kwatha Shirodhara in management of
Anidra in 2 weeks 		 To determine efficacy of Tagar kwatha Shirodhara as compared to Jatamansi kwatha Shirodhara in management of
Anidra in 2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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)   06/02/2025 
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="1"
Months="0"
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   Anidra is symptom which is related to different psychiatric disorders, medical disorder or circadian rhythm disorder .It can be caused by improper lifestyle or work schedule. It is a medical condition which affects difficulty falling asleep , staying asleep , or waking up too early. It leads to higher risk of health problems . As Vaikariki Nidra can be considered as sleep disorder .Acharya Vagbhatt used the term  Asvpna as Vataja Nanatmaja Vikara. It may lead to following symptoms like Manodaurbalya (lack of concenteration ),
Smiritidaurbalya (lack of memory), Indriya Karmahani (poor sensory perception),  Ajirna (Indigestion), Agnimandya(Anorexia), Malabaddhata(Constipation), Dhatukshaya(Weight loss). So, if it is left untreated it may lead tom reduction in mental capacity on individual, reduce efficacy , it may drag the individual towards several Psychosomatic disorders.
Shirodhara is a classical method and a type of Murdha taila. Pouring of Mediacated kwath(decoction) or oil on forehead is a type of Bahyasnehana.
The study is about comparing the effect of Tagar kwath Shirodhara with Jatamansi kwath Shirodhara in management of Anidra 
 
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