| CTRI Number |
CTRI/2026/02/102812 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
02/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical Evaluation of a Traditional Herbal Oil Application for Improving Sleep in Chronic Insomnia |
|
Scientific Title of Study
|
Therapeutic Efficacy and Safety of Karaskara Keram (Anubhuta Yoga) as external application over head in the Management of Chronic Insomnia: A Randomized, Controlled, Single-Blind Clinical Trial |
| 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 Govindan Namboodiri |
| Designation |
Professor |
| Affiliation |
Glocal University |
| Address |
Room No 1
Department of
Kayachikitsa
Research Wing,
Saharanpur
UTTAR PRADESH
247121
India |
| Phone |
9447389578 |
| Fax |
|
| Email |
drgovindan@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kasthuri Nair A |
| Designation |
Asso Professor |
| Affiliation |
Pankajakasthuri Ayurveda Medical College and PG Centre |
| Address |
Room No2 Department of Kayachikitsa
Thiruvananthapuram
KERALA
695572
India |
| Phone |
8113851665 |
| Fax |
|
| Email |
dr.kasthurinair@pkhil.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kasthuri Nair A |
| Designation |
Asso Professor |
| Affiliation |
Pankajakasthuri Ayurveda Medical College and PG Centre |
| Address |
Room No2 Department of Kayachikitsa
KERALA
695572
India |
| Phone |
8113851665 |
| Fax |
|
| Email |
dr.kasthurinair@pkhil.com |
|
|
Source of Monetary or Material Support
|
| Pankajakasthuri Ayurveda Medical College and PG Centre
Kattakada
Thiruvananthapuram
KERALA
India
Pin : 695572
|
|
|
Primary Sponsor
|
| Name |
Dr Kasthuri Nair A |
| Address |
Asso Professor
Room No 2
Department of Kayachikitsa
Pankajakasthuri Ayurveda Medical College and PG Centre
Kattakada
Thiruvananthapuram
KERALA
India
Pin : 695572
|
| Type of Sponsor |
Other [Student funded project] |
|
|
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 |
| Dr Kasthuri Nair A |
Pankajakasthuri Ayurveda Medical College & PG Centre |
Room No:2 Department of kayachikitsa Pankajakasthuri Ayurveda Medical college and PG centre Killy Thiruvananthapuram
Thiruvananthapuram
KERALA |
8113851665
dr.kasthurinair@pkhil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee of Pankajakasthuri Herbal Research Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G89-G99||Other disorders of the nervous system. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Karaskara Keram, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 30 Days, Reference: NA, Route: -, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm (Non Ayurveda) | | - | Kerathaila (coconut oil) | Participants allocated to the control group will receive Kerathaila (coconut oil) as the comparator intervention. A measured dose of 5 ml of kerathaila will be applied externally over the vertex of the head, followed by gentle scalp massage for 15–20 minutes. The application will be performed once daily in the morning prior to head bath for a continuous duration of four weeks. |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Clinical diagnosis of Insomnia Disorder in accordance with DSM-5 criteria for a minimum duration of three months
Baseline Insomnia Severity Index (ISI) score less than 7, indicating at least subthreshold insomnia.
Willingness to comply with trial procedures and provide written informed consent. |
|
| ExclusionCriteria |
| Details |
Psychiatric comorbidities including schizophrenia, major depressive disorder, psychosis, epilepsy, or anxiety disorders.
2. Substance use disorders including alcohol or drug dependency.
3. Other primary sleep disorders such as narcolepsy, circadian rhythm disorders, parasomnias, or sleep-disordered breathing.
4. Chronic systemic diseases such as asthma, malignancies, liver cirrhosis, uncontrolled hypertension, diabetes mellitus, and chronic kidney disease.
5. Recent use of hypnotic medications or psychotherapy within the past four weeks.
6. Those who are having dandruff, alopecia and such kinds of Shiroroga.
7. Pregnant and lactating women.
8. Patients with a history of neurosurgical interventions including brain tumours.
Those who are not willing to sign the informed consent.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in insomnia severity and sleep quality assessed using validated sleep scales:
• Insomnia Severity Index (ISI)
• Pittsburgh Sleep Quality Index (PSQI)
• Epworth Sleepiness Scale (ESS)
• Regensburg Insomnia Scale (RIS)
|
Primary Outcome Assessment Time Point(s)
Baseline (Day 0)
Mid-treatment (DAY 15)
End of treatment (DAY 29)
Post-treatment follow-up (DAY 43)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in objective & subjective sleep parameters as recorded in a daily sleep diary, including sleep onset latency, number of nocturnal awakenings, total sleep time, & sleep efficiency.
2. Improvement in overall sleep quality & satisfaction, assessed through subjective participant reports & investigator evaluation.
3. Change in psychological status, assessed using Depression Anxiety Stress Scale (DASS-42).
4. Change in health-related quality of life, assessed using the SF-36 questionnaire.
5. Safety & tolerability, assessed through participant-reported local adverse effects (pruritus, burning sensation, stinging) using a Visual Analog Scale (VAS: 0–10) & clinical monitoring.
|
Secondary Outcome Assessment Time Point(s)
Baseline (Day 0)
Mid-treatment (DAY 15)
End of treatment (DAY 29)
Post-treatment follow-up (DAY 43)
|
|
|
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 |
|
Date of First Enrollment (India)
|
11/01/2027 |
| 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) |
Open to Recruitment |
|
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
|
Background:
Chronic insomnia is a prevalent sleep disorder associated with impaired quality
of life, psychological distress, and increased risk of chronic morbidity.
Conventional pharmacological treatments often have limitations related to
tolerance, dependency, and adverse effects, highlighting the need for safe and
effective complementary interventions. Karaskara Keram, an Ayurvedic Anubhuta
Yoga prepared using Strychnos nux-vomica processed according to
classical purification and taila paka principles, is traditionally used as an
external therapy for sleep disturbances.
Aim:
To evaluate the therapeutic efficacy and safety of Karaskara Keram applied
externally over the head in the management of chronic insomnia.
Methods:
This is a randomized, controlled, single-blind, parallel-arm clinical trial
conducted at a tertiary Ayurveda care center. A total of 62 patients aged 20–70
years, diagnosed with chronic insomnia as per DSM-5 criteria and having an
Insomnia Severity Index (ISI) score >7, will be enrolled and randomized into
two groups. The trial group will receive 5 ml of Karaskara Keram applied over
the vertex of the head with gentle scalp massage for 15–20 minutes daily before
head bath for four weeks. The control group will receive kerathaila in an
identical manner. Primary outcomes include changes in ISI, Pittsburgh Sleep
Quality Index (PSQI), Epworth Sleepiness Scale (ESS), and Regensburg Insomnia
Scale (RIS). Secondary outcomes assess sleep diary parameters, psychological
status using DASS-42, quality of life using SF-36, and safety through clinical
monitoring and laboratory investigations. Statistical analysis will be
performed using appropriate parametric or non-parametric tests with a
significance level set at p < 0.05.
Expected Outcome:
The study aims to generate scientific evidence on the
efficacy, safety, and tolerability of Karaskara Keram as a non-pharmacological,
external Ayurvedic intervention for chronic insomnia.
|