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CTRI Number  CTRI/2025/04/085702 [Registered on: 25/04/2025] Trial Registered Prospectively
Last Modified On: 24/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of sarpgandha churna yoga in anidra(insomnia) 
Scientific Title of Study   A Clinical study of Sarpagandha churna yoga in the management of Anidra with special reference to 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 Avinash kumar 
Designation  MD(Ayu)Scholar 
Affiliation  Institute of medical science Bhu 
Address  Department of Kayachikitsa Dhanwantri Bhawan Faculty of Ayurveda Institute of medical science Banaras Hindu University Varanasi UP

Varanasi
UTTAR PRADESH
221005
India 
Phone  9125505179  
Fax    
Email  kumar.avinash110@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof K H H V S S Narasimha Murthy 
Designation  professor 
Affiliation  Institute of medical science Bhu 
Address  Department of Kayachikitsa Dhanwantri Bhawan Faculty of Ayurveda Institute of medical science Banaras Hindu University Varanasi UP

Varanasi
UTTAR PRADESH
221005
India 
Phone  9415813570  
Fax    
Email  k_narasimhamurthy@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Prof K H H V S S Narasimha Murthy 
Designation  professor 
Affiliation  Institute of medical science Bhu 
Address  Department of Kayachikitsa Dhanwantri Bhawan Faculty of Ayurveda Institute of medical science Banaras Hindu University Varanasi UP

Varanasi
UTTAR PRADESH
221005
India 
Phone  9415813570  
Fax    
Email  k_narasimhamurthy@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Kayachikitsa faculty of Ayurveda IMS BHU Varanasi Uttar Pardesh 221005 India  
 
Primary Sponsor  
Name  Department of Kayachikitsa  
Address  Dhanwantri Bhawan, Faculty of Ayurveda IMS BHU Varanasi Uttar pradesh 221005 
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 Avinash kumar  Sir Sundar Lal Hospital BHU Varanasi  Kayachikitsa OPD Room no.21-22 Indian medicine wing Banaras Hindu University Varanasi 221005
Varanasi
UTTAR PRADESH 		 9125505179

kumar.avinash110@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee institute of medical science bhu  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G470||Insomnia. Ayurveda Condition: NIDRANASAH/ASVAPNAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Sarpagandha churna yoga, Reference: Rasatanta sar va siddha prayoga samgraha part 2, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator Arm (Non Ayurveda)-Tab. Placeboit contains gelatin filled capsule
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients presenting with complaints of Reduction of sleep time, Difficulty in initiation of sleep, Wakefulness during normal sleep, either any of these or all of these for the duration of 3 months or more. Criteria for diagnosis-Based on classical signs and symptoms of Anidra 
 
ExclusionCriteria 
Details  Patient above 50 years.
Patients with severe psychic disease.
Patient with moderate and severe hypertension, Stroke, Hemorrhagic disorders, Epilepsy.
Patient with alcohol dependency or drug dependency will be excluded from study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
assessment of improvement in sign and symptom of insomina disease and athens insomnia scale and pittsburgh sleep quality index   45 days with 3 follow up 15,30,45 days 
 
Secondary Outcome  
Outcome  TimePoints 
assessment of improvement in subjective & objective criteria of insomnia   0, 15,30,45 days assessment with follow-ups in subjective & objective criteria 
 
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)   05/05/2025 
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 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   Insomnia is most prevalent sleep disorder in current Era. In this study the effect of sarpagandha churna yoga and placebo will be used in the management of insomnia. Patient will be selected on the basis of subjective and objective criteria .The assessment of result will be based on clinical and subjective assessment of patient during the trial period. 
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