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CTRI Number  CTRI/2024/07/071043 [Registered on: 23/07/2024] Trial Registered Prospectively
Last Modified On: 01/04/2026
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   A Randomized Comparative Clinical Study to evaluate the efficacy of Hibiscus powder and Karnapoorana with Ksheerabala Oil in the management of Insomnia 
Scientific Title of Study   A Randomized comparative Clinical Study to evaluate the efficacy of Japa pushpa Churna and Karnapoorana with Ksheerabala Taila in the management of Anidra vis-a-vis 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 Deepu CN 
Designation  PG Scholar 
Affiliation  Sushrutha Ayurvedic medical college and hospital 
Address  Room No 5, Department of Kayachikitsa, Department of PG studies Division, Sushrutha Ayurvedic Medical College and Hospital
Prashanthi Kuteera, Jodi Bingipura, Jigani, Anekal Taluk
Bangalore
KARNATAKA
560105
India 
Phone  7619629722  
Fax    
Email  deepucn35@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vajrala Venkat Ram Reddy 
Designation  Professor and HOD 
Affiliation  Sushrutha Ayurvedic medical college and hospital 
Address  Room No 5, Department of Kayachikitsa, Department of PG studies, Sushrutha Ayurvedic Medical College and Hospital
Prashanthi Kuteera, Jodi Bingipura, Jigani, Anekal Taluk
Bangalore
KARNATAKA
560105
India 
Phone  7619629722  
Fax    
Email  ramreddyv9@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Deepu CN 
Designation  PG Scholar 
Affiliation  Sushrutha Ayurvedic medical college and hospital 
Address  Room No 5, Department of Kayachikitsa, Department of PG studies Division, Sushrutha Ayurvedic Medical College and Hospital
Prashanthi Kuteera, Jodi Bingipura, Jigani, Anekal Taluk
Bangalore
KARNATAKA
560105
India 
Phone  7619629722  
Fax    
Email  deepucn35@gmail.com  
 
Source of Monetary or Material Support  
Department of Kayachikitsa, Department of PG studies Division, Sushrutha Ayurvedic Medical College and Hospital, Prashanthi Kuteera, Jodi Bingipura, Jigani, Anekal Taluk, Bengaluru, Karnataka, India - 560105 
 
Primary Sponsor  
Name  Dr Deepu CN 
Address  Sushrutha Ayurvedic Medical College and Hospital, Prashanthi Kuteera, Jodi Bingipura, Jigani, Anekal Taluk, Bengaluru, Karnataka, India - 560105 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Sushrutha Ayurvedic Medical College and Hospital  Prashanthi Kuteera, Jodi Bingipura, Jigani, Anekal Taluk, Bengaluru - 560105 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Deepu C N  Sushrutha Ayurvedic Medical College and Hospital  Room No 4, Department of Kayachikitsa, Out Patient Department, Prashanthi Kuteera, Jodi Bingipura, Jigani, Anekal Taluk
Bangalore
KARNATAKA 		 7619629722

deepucn35@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee SAMC and H  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F510||Insomnia not due to a substance orknown physiological condition. Ayurveda Condition: NIDRANASAH/ASVAPNAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-karNapUraNam, कर्णपूरणम् (Procedure Reference: Ashtanga Hridaya, Suthrasthana 7, verse 66, Procedure details: Patient is made to lie in left lateral position initially. Abhyanga to ear is done followed by mild fomentation. Then warm oil is instilled into the ear with the help of cotton/ dropper till the ear cavity gets filled. Subjecct should be in that position for 2 minutes 24 seconds. Then oil is slowly removed using cotton/ dropper. Ear cavity is cleaned & mild fomentation is given again. Cotton plug is placed inside the ear. Similar procedure is repeated in the other ear also)
(1) Medicine Name: Ksheerabala, Reference: Sahasrayoga, Taila yoga prakarana, Route: Otic, Dosage Form: Taila, Dose: 5(ml), Frequency: hs, Duration: 30 Days
2Intervention ArmDrugOther than Classical(1) Medicine Name: Japa Pushpa, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Warm water), Additional Information: -
3Comparator ArmDrugOther than Classical(1) Medicine Name: Placebo, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Warm water), Additional Information: -
4Intervention ArmProcedure-karNapUraNam, कर्णपूरणम् (Procedure Reference: Ashtanga Hridaya, Suthrasthana 7, verse 66, Procedure details: Patient is made to lie in left lateral position initially. Abhyanga to ear is done followed by mild fomentation. Then warm Ksheerabala taila is instilled into the ear with the help of cotton/ dropper till the ear cavity gets filled. Subject should be in that position for 2 minutes 24 seconds. Then oil is slowly removed using cotton/ dropper. Ear cavity is cleaned & mild fomentation is given again. Cotton plug is placed inside the ear. Similar procedure is repeated in the other ear also.)
(1) Medicine Name: Ksheerabala, Reference: Sahasrayoga, Taila yoga prakarana, Route: Otic, Dosage Form: Taila, Dose: 5(ml), Frequency: hs, Duration: 30 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects who fit to the diagnostic criteria
Subjects suffering from Insomnia occurrin atleast 3 times a week for one month
Subjects who fit for karnapoorana
Subjects willing to provide informed consent
Subjects who arer under any medication interfering with the current study but has discontinued one month prior to the study 
 
ExclusionCriteria 
Details  Subjects with any systemic diseases and medications which interfere with the disease process and present clinical trial will be excluded
Subjects with major psychiatric illness like schizophrenia, epilepsy, depressive psychosis will be excluded
Insomnia due to substance abuse and trauma will be excluded
Physiological conditions like pregnancy, lactation and puerperal stage will be excluded
Subjects planning for conception will be excluded
 
 
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   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in the symptoms of Insomnia is assessed using Insomnia Severity Index Scale  15th and 30th day 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in induction & maintainence of the sleep using Insomnia Severity Index Scale  15th day & 30th day 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   10/08/2024 
Date of Study Completion (India) 03/05/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 03/05/2025 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  		 This study is a randomized, comparative clinical trial to evaluate the efficacy of Japa pushpa churna (Hibiscus rosa sinensis) 3gms twice daily and Karnapoorana with Ksheerabala taila for 100 matra kala (2 mins 24 secs) in Group A with minimum of 20 subjects , placebo and Karnapoorana with Ksheerabala taila for 100 matra kala (2mins 24 secs) in Group B with minimum of 20 subjects in the management of Anidra vis-a-vis Insomnia for a period of 30 days. The primary outcome is improving the sleep quality and the secondary outcome is improving the quality of life. 
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