| CTRI Number |
CTRI/2025/04/085895 [Registered on: 29/04/2025] Trial Registered Prospectively |
| Last Modified On: |
09/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This study is to compare the efficacy of shirobasti(a therapeutic oil application method)and padabhyanga(foot massage) with tungadrumadi taila in the condition of Anidra Insomnia |
|
Scientific Title of Study
|
A Randomised comparative clinical study to evaluate the effect of shirobasti and padabhyanga with Tungadrumadhi Taila in the management of Anidra 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 |
Dr Vellala Bhavana |
| Designation |
2nd year MD |
| Affiliation |
Shree Shivayogeeshwara rural ayurvedic medical College and hospital Inchal |
| Address |
Shree Shivayogeeshwara rural ayurvedic medical College and hospital Inchal department of panchakarma room no 35
Belgaum
KARNATAKA
591102
India |
| Phone |
9686752199 |
| Fax |
|
| Email |
vellalabhavyasree@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G S Hadimani |
| Designation |
Professor |
| Affiliation |
Shree Shivayogeeshwara rural ayurvedic medical College and hospital Inchal |
| Address |
Shree Shivayogeeshwara rural ayurvedic medical College and hospital Inchal belgavi dist savadatti TQ department of panchakarma room no 35
Belgaum
KARNATAKA
591102
India |
| Phone |
9632755707 |
| Fax |
|
| Email |
gshadimani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Sangolli |
| Designation |
Assistant professor |
| Affiliation |
Shree Shivayogeeshwara rural ayurvedic medical College and hospital Inchal |
| Address |
Shree Shivayogeeshwara rural ayurvedic medical College and hospital Inchal department of panchakarma room no 35
Belgaum
KARNATAKA
591102
India |
| Phone |
7349085614 |
| Fax |
|
| Email |
ashwiniasangolli1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Shivayogeeshwara rural ayurvedic medical College and hospital Inchal 591102 TQ Savadatti dist Belagavi
Karnataka
India |
|
|
Primary Sponsor
|
| Name |
Dr Vellala Bhavana |
| Address |
Department of panchakarma room no 35 Shree Shivayogeeshwara rural ayurvedic medical College and hospital Inchal TQ Savadatti dist Belagavi |
| Type of Sponsor |
Other [Self] |
|
|
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 Vellala Bhavana |
Shree Shivayogeeshwara rural ayurvedic medical College and hospital in |
Shree Shivayogeeshwara rural ayurvedic medical College and hospital Inchal TQ Savadatti dist Belagavi
Room no 35 department of panchakarma
Belgaum
KARNATAKA |
9686752199
vellalabhavyasree@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shree Shivayogeeshwara rural ayurvedic medical College and hospital Inchal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F068||Other specified mental disorders due to known physiological condition. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | SirobastiH, शिरोबस्तिः | (Procedure Reference: Charakasamhita, Procedure details: Lukewarm oil is pourded over the scalp till it reaches two angula above the midscalp.Constanttemperature of oil is maintained through out the procedure by constant shuffling of oil.Same procedure is continued based on severity of disease)
(1) Medicine Name: Tungadrumadhi Taila , Reference: Sahasrayoga , Route: Topical, Dosage Form: Taila, Dose: 250(ml), Frequency: od, Duration: 07 Days | | 2 | Comparator Arm | Procedure | - | Pada abyanga | (Procedure Reference: Charaka samhita, Procedure details: Lukewarm oil is applied to the foot gently Massage gently on the inner foot from heal to toes Massage outer surface from heal to toes Massage anterior surface & plantar surface Apply gentle pressure in circular motion to ankle from both sides Give massage to each and every toe and inner toe places)
(1) Medicine Name: Tungadrumadhi Taila , Reference: Sahasrayoga, Route: Topical, Dosage Form: Taila, Dose: 25(ml), Frequency: od, Duration: 07 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects irrespective of sex presenting with the lakshanas of Anidra |
|
| ExclusionCriteria |
| Details |
Pregnant & Lactating mother
Subjects with any other systemic disorders that interfere with the course of
treatment. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Symptoms of Anidra reduced |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Overall improvement of sleep cycle and health |
14 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/ Phase 3 |
|
Date of First Enrollment (India)
|
20/05/2025 |
| 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="0"
Months="0"
Days="14" |
|
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
|
Although Anidra is not directly available in our Samhitas as a disease but it is mentioned as symptom in various other diseaeses .It has been stated as one among the 80 Vataja Nanatamaja Vyadhis3 It is a major symptom of many disease 4 Nidra bramsha is mentioned in Vata vridhi lakshana & Alpanidrata is mentioned as Pitta vridhi lakshana by Acharya Vagbhatta 5 |