| CTRI Number |
CTRI/2026/01/101952 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
20/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Two Ayurvedic Forehead Oil Therapies for Sleep Problems |
|
Scientific Title of Study
|
Comparative Open Label Double Arm Clinical Trial to Study the efficacy of Lalata Basti and Lalata Pichu with Tungadrumadi Taila in Management of Nidranasha (Primary 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 Swastika Chandel |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department of Panchakarma
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
Thanniruhalla Hassan Karnataka India
Hassan
KARNATAKA
573201
India |
| Phone |
8727957174 |
| Fax |
|
| Email |
swatichandel1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B A Lohith |
| Designation |
Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department of Panchakarma
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
Thanniruhalla Hassan Karnataka India
Hassan
KARNATAKA
573201
India |
| Phone |
9886749168 |
| Fax |
|
| Email |
drlohithpk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr B A Lohith |
| Designation |
Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department of Panchakarma
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
Thanniruhalla Hassan Karnataka India
Hassan
KARNATAKA
573201
India |
| Phone |
9886749168 |
| Fax |
|
| Email |
drlohithpk@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College of Ayurveda and Hospital, Thanniruhalla, Hassan 573201 |
|
|
Primary Sponsor
|
| Name |
SDM College of Ayurveda and Hospital |
| Address |
Thanniruhalla, Hassan 573201 |
| Type of Sponsor |
Private medical college |
|
|
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 Swastika Chandel |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA & HOSPITAL |
OPD and IPD under all the departments of Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Thanniruhalla, Hassan 573201
Hassan
KARNATAKA
Hassan
KARNATAKA |
8727957174
swatichandel1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Of Ethics Committee Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital Hassan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G470||Insomnia. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Lalata Basti | (Procedure Reference: Astanga Hridaya Sutrasthan 22, Procedure details: The patient is placed comfortably in the supine position. A dough ring made of wheat flour is fixed over the forehead to form a leak-proof cavity. Warm medicated oil is poured into this cavity & maintained at a warm temperature by periodic replacement for a total duration of 53 minutes. After completion, the dough ring is removed & a gentle forehead massage is given. The participant is advised to avoid wind, cold exposure, & stress immediately after the procedure.)
(1) Medicine Name: Tungadrumadi Taila, Reference: Sahasrayogam Taila Prakaranam, Route: Topical, Dosage Form: Taila, Dose: 50(mg), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | Lalata Pichu | (Procedure Reference: Astanga Hridaya Sutrasthan 22, Procedure details: A cotton Pichu soaked in warm medicated oil is placed over the Lalata Pradesh, covering the area between the eyebrows and the anterior hairline, and retained for 53 minutes while maintaining warmth. After removal, the forehead is gently cleaned and given a mild massage. The participant is advised to avoid wind, cold exposure, and stress immediately after the procedure.)
(1) Medicine Name: Tungadrumadi Taila, Reference: Sahasrayogam Taila Prakaranam, Route: Topical, Dosage Form: Taila, Dose: 50(mg), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Subject fulfilling diagnostic criteria
2 Subject aging between 18-60 years
3 Subjects irrespective of gender
4 Subjects willing to sign informed consent form |
|
| ExclusionCriteria |
| Details |
1 Known case of alcoholism
2 Known case of psychiatric illness
3 Subject suffering from ajeerna
4 Subjects receiving any medications that cause sedation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparative improvement in the clinical features of Nidranasha between Lalata Basti and Lalata Pichu groups
|
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in quality of sleep |
30 Days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/02/2026 |
| 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="2"
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
|
Research from different parts of the world reveals that insomnia impacts a significant portion of the population usually between 10% - 30%, and sometimes even up to 50%- 60%. Also, about 4% of the population use sleeping pills in a regular basis. It has been found that 18.6% of the South India population are diagnosed with primary insomnia. Insomnia is characterized by a subjective difficulty in initiating or maintaining sleep, or experiencing non-restorative sleep, despite adequate time and environment for sleep leading to significant daytime dysfunction or distress.Shirobasti is one among the Moordhnitaila, a Bahirparimarjana Chikitsa done over the Shiras. The Lalata Basti is conceptualized from Shiro Basti. In this sneha is made to retain over the forehead for a stipulated period of time. Lalata Basti is technically demanding due to the forehead’s curvature and the difficulty in retaining medicated oil effectively, it requires continuous monitoring to prevent leakage and maintain therapeutic temperature, making it labor-intensive. Whereas the proposed Lalata Pichu therapy minimizes procedural complexity while ensuring sustained local action of the medicated oil. It will allow uniform absorption of the drug without the need for complex setup or continuous monitoring Tungadrumadi Taila is selected as it has Vatapittahara and Shitaveerya property. Ingredients of Tungadrumadi Taila are- Sugandha, Lamajja, Yashtimadhu, Utpala, Shvetachandana, Tungadruma, Dugdha and Tila The present study is designed with the intent to evaluate the efficacy of Lalata Pichu as a potential alternative to Lalata Basti, considering its simpler application, minimal postural requirement, and resource optimization. If proven effective, Lalata Pichu may serve as a standardized Panchakarma intervention, thereby contributing to the clinical utility in managing Nidranasha. |