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CTRI Number  CTRI/2025/04/084450 [Registered on: 09/04/2025] Trial Registered Prospectively
Last Modified On: 08/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Clinical trial to evaluate the efficacy of Shiroabhyanga with Ksheerabala taila in the management of Nidranash  
Scientific Title of Study   Randomized Clinical trial to evaluate the efficacy of Shiroabhyanga with Ksheerabala taila in the management of Nidranash w.s.r 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  Shrikant Vaijnath Rajmane 
Designation  MD(Panchakarma) Scholar 
Affiliation  Late Kedari Redekar Ayurvedic Mahavidyalaya,Gadhinglaj 
Address  Department of Panchakarma,Late Kedari Redekar Ayurvedic Mahavidyalaya,Gadhinglaj
P-2, MIDC Area,Shendri Mal, Gadhinglaj,Dist-Kolhapur - 416502
Kolhapur
MAHARASHTRA
416502
India 
Phone  9766195753  
Fax    
Email  shrikantrajmane809@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tanuja Gaikwad 
Designation  Professor & HOD of Panchakarma department  
Affiliation  Late Kedari Redekar Ayurvedic Mahavidyalaya,Gadhinglaj 
Address  Department of Panchakarma,Late Kedari Redekar Ayurvedic Mahavidyalaya,Gadhinglaj.
P-2, MIDC Area,Shendri Mal, Gadhinglaj,Dist-Kolhapur - 416502
Kolhapur
MAHARASHTRA
416502
India 
Phone  7588335343  
Fax    
Email  gaikwadtanuja14@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Tanuja Gaikwad 
Designation  Professor & HOD of Panchakarma department  
Affiliation  Late Kedari Redekar Ayurvedic Mahavidyalaya,Gadhinglaj 
Address  Department of Panchakarma,Late Kedari Redekar Ayurvedic Mahavidyalaya,Gadhinglaj.
P-2, MIDC Area,Shendri Mal, Gadhinglaj,Dist-Kolhapur - 416502
Kolhapur
MAHARASHTRA
416502
India 
Phone  7588335343  
Fax    
Email  gaikwadtanuja14@gmail.com  
 
Source of Monetary or Material Support    
Primary Sponsor  
Name  Late Kedari Redekar Ayurvedic Mahavidyalaya,Gadhinglaj 
Address  P-2, MIDC Area,Shendri Mal, Gadhinglaj,Dist-Kolhapur - 416502 
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 
Shrikant Vaijnath Rajmane   Late Kedari Redekar Ayurvedic Mahavidyalaya,Gadhinglaj  Department of Panchakarma,Late Kedari Redekar Ayurvedic Mahavidyalaya,Gadhinglaj P-2, MIDC Area,Shendri Mal, Gadhinglaj,Dist-Kolhapur - 416502
Kolhapur
MAHARASHTRA 
9766195753

shrikantrajmane809@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee Late Kedari Redekar Ayurvedic Mahavidyalaya,Gadhinglaj   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
1Intervention ArmDrugClassical(1) Medicine Name: Ksheerabala Taila , Reference: R.Vidyanath and K.Nishteswar,Edited and published,Sahasrayogam,Taila prakarana,no 3, Ksheerabala Taila, page no 110,Reprint 2008,Publisher chowkhamba Sanskrit series office, varanasi., Route: Topical, Dosage Form: Taila, Dose: 25(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: No
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patient above 20 and below 60 years of age group
2.Patient of both the genders are included
3.Sleep disturbance occurs at least 3 times per week and has been problem for at least 1 month
4. Patient ready to give written informed consent  
 
ExclusionCriteria 
Details  1.Patients who are unfit for Abhyanga according to ayurvedic classics
2.Any patients suffering from known systemic illness or any chronic health disorder
3.Patients with Psychiatric diagnosis are excluded from this study were receiving any medication and drug that could cause sedation
4. Pregnant ladies and lactating mothers  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Ksheerabala Taila Shiroabhyanga in the management of Nidranash w.s.r to insomnia  On 0th,7th,14th,21st day of trial. 
 
Secondary Outcome  
Outcome  TimePoints 
1.To study the Nidranash and insomnia according to Ayurveda and modern science respectively in detail, along with mode of action of Shiroabhyanga.
2.To study Ksheerabala Taila in detail. 
On 0th 7th 14th 21st day of trial. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   25/04/2025 
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="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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [shrikantrajmane809@gmail.com].

  6. For how long will this data be available start date provided 10-05-2025 and end date provided 10-05-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Ayurveda is a science of life, aim of ayurveda is not only to cure the diseased person but also maintain the health of healthy person’s. 

According to Sushruta definition of health is very comprehensive, Health is all the three Doshas in the same level, with that Sama Agni, Sama Dhatu, Mala Kriya also important, along with that Atma, Indriya and mind becomes happy. In the treatment of Ayurveda Sharira and Manas Bhavas are also considered,

Acharya Vagbhata has mentioned Ahara, Nidra and Brahmacharya a Trayoupastambha.These three factors play an important role in the maintenance of health of a human being.

Sukha, Dukkha, Pushti, Karshyam, Vrushta, Klibata, Gyana and Agyana, Jivitva and Ajivitva all these factors depends on Nidra, Asamyak Nidra causes opposite to all of these.

Nidranash can be correlated with insomnia described in Modern medical science by the similarity of the sign and symptoms.

The cumulative long-term effects of sleep disorders and sleep loss have been associated with the wide range of health problems including an increased risk of hypertension, diabetes, obesity, depression, heart attack and stroke.

Occasionally episodes of insomnia may come and go without causing any serious problems, but for some people it can last for months or even years at a time.

Persistent insomnia can have a significant impact on your quality of life, It can limit what you are able to do during the day affect your mood,and lead to relationship problems with friends, family and colleagues.

Panchakarma presents a unique approach of ayurveda in promotive, preventive and curative aspects, it is a comprehensive and an integral part of ayurvedic treatment and has it’s role in every therapeutic condition.

Acharya Charaka has mentioned Murdha Taila treatment for Nidranash, In Murdha Taila there are four types of therapy Shiroabhyang, Shiropichu, Shirodhara, and Shirobasti. In Panchakarma Shiroabhyanga is considered as one of the snehana karma widely practiced for treating vatavyadhis like nidranash, In this disease vata is vitiated either due to Pitta, Kaph Prakop or by it’s own Hetu.

In Nidra Tama Guna and Kaph are increases in the body but due to Vata Prakop Kaph Kshay occurs and Raj Gunatmak Vata is increases so Toma Guna get reduces and Nidranash occurs.

The conventional anxiotic and sedative drugs have limited application due to hangover effects, addiction and producing variety of neuroscience hepatic side effects, such drugs also badly influences the cognitive performance particularly memory and attention of the individual therefore such drugs can’t be given for a longer period.

But in ayurveda along with internal medicines there are many external therapeutic measures which can be used, Bahya Snehana like Shiroabhyanga can be used in Nidranash for external application, Hence I have selected Ksheerabala Taila which is having properties of Vata and Pitta Shamana, Nidranash is one of the Vataj Nanatmaj Vyadhi in the eighty vataj Nanatmaj Vyadhi considered by Charak Acharya and according to Chakrapani also it causes due to Vatapradhan Dosh.
 
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