| CTRI Number |
CTRI/2024/06/069034 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
15/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparing the effect of Foot Patch and Padabhyanga in Nidranasha |
|
Scientific Title of Study
|
Comparative clinical study to evaluate the effectiveness of Padabhyanga and Modified Pada Pichu Bandhana in 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 TEJASWINI RAMESH HEGDE |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan |
| Address |
Department of PanchakarmaSri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla Benguluru Mangalore Highway Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9449829649 |
| Fax |
|
| Email |
pg22144@sdmcahhassan.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Muralidhar P Pujar |
| Designation |
Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan |
| Address |
Department of Panchakarma Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla Benguluru Mangalore Highway Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9448033718 |
| Fax |
|
| Email |
drmuralidharpujar@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Muralidhar P Pujar |
| Designation |
Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan |
| Address |
Department of Panchakarma Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla Benguluru Mangalore Highway Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9448033718 |
| Fax |
|
| Email |
drmuralidharpujar@sdmcahhassan.org |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla 573201 Hassan, Karnataka India |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital B M Road, Thanniruhalla, Hassan-573201 Karnataka, India |
| 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 Tejaswini Ramesh Hegde |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan |
Department of Panchakarma Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla Benguluru Mangalore Highway Hassan
Hassan
KARNATAKA |
9449829649
pg22144@sdmcahhassan.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee 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 | - | picu, पिचॠ| (Procedure Reference: Astanga Hrudaya, Procedure details: Modified Padapichu bandhana for 7 days)
(1) Medicine Name: Go Ghrita, Reference: Ashtanga Hrudaya, Route: Topical, Dosage Form: Ghrita, Dose: 10(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | aBya~ggaH, अà¤à¥à¤¯à¤‚ग | (Procedure Reference: Ashtanga Sangraha, Procedure details: Padabhyanga for 7 days)
(1) Medicine Name: Go Ghrita, Reference: Ashtanga Hrudaya, Route: Topical, Dosage Form: Ghrita, Dose: 10(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects fulfilling diagnostic criteria.
2.Subjects aging between 20 to 70 years.
3.Subjects of all gender.
4.Subjects willing to sign consent form.
|
|
| ExclusionCriteria |
| Details |
1.Known case of alcoholism.
2.Known case of psychiatric illness.
3.Previously diagnosed medical or surgical disorders.
4.Subjects suffering from Ajeerna.
5.Subjects receiving any medications that cause sedation.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment will be based on improvement in Jrumbha,Angamarda Tandra,Bhrama,Apakti,Jadyata,Glani,Shirogaurava and Insomnia Severity index scale
|
15 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Insomnia Severity index scale |
15 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)
|
28/06/2024 |
| 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="2"
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 - NO
|
|
Brief Summary
|
Insomnia affects 10%–30% of the global population,
with existing pharmaceutical interventions facing limitations due to adverse
effects. Padabhyanga is acknowledged for treating Nidranasha, and ongoing
research aims to compare the efficacy of Pada Pichu Bandhana and Padabhyanga.
Evaluating the effectiveness of adhesive foot patches, incorporating Go Ghrita
to balance Vata and Pitta Doshas, is a novel approach. This study explores the
potential of modified Pada Pichu Bandhana through adhesive patches, offering a
convenient alternative for insomnia management. |