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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:F489||Nonpsychotic mental disorder, unspecified. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shrikantrajmane809@gmail.com].
- 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.
- 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. |