| CTRI Number |
CTRI/2025/03/081986 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
22/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
effect of a lifestyle based integrative medicine program on sleep and mental health in older adults with restless leg syndrome |
|
Scientific Title of Study
|
To Study the Effect of Structured Integrative Medicine Lifestyle Approach as an Add-on Therapy on Symptom Severity and Mental Health Related Outcomes in Elderly with Restless Leg Syndrome- An Exploratory Randomized Control 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 |
Pankhuri Saxena |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
6th floor, Department Of Geriatric Medicine, AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8979336334 |
| Fax |
|
| Email |
pankhurisaxena96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MONIKA PATHANIA |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF GERIATRIC MEDICINE, AIIMS RISHIKESH
UTTARANCHAL
249203
India |
| Phone |
8126021556 |
| Fax |
|
| Email |
anshupathania27@gmail |
|
Details of Contact Person
Public Query
|
| Name |
Pankhuri Saxena |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
6th FLOOR, DEPARTMENT OF GERIATRIC MEDICINE, AIIMS RISHIKESH
UTTARANCHAL
249203
India |
| Phone |
8979336334 |
| Fax |
|
| Email |
pankhurisaxena96@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS RISHIKESH, RISHIKESH-249203, UTTARAKHAND, INDIA |
|
|
Primary Sponsor
|
| Name |
PANKHURI SAXENA |
| Address |
DEPARTMENT OF GERIATRIC MEDICINE, AIIMS RISHIKESH |
| Type of Sponsor |
Government 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 PANKHURI SAXENA |
AIIMS rishikesh |
6TH FLOOR, GERIATRIC MEDICINE, AIIMS RISHIKESH, RISHIKESH- 249203
Dehradun
UTTARANCHAL |
08979336334
pankhurisaxena96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE AIIMS RISHIKESH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ABHYANGA |
Arm 1 will receive a standardized abhyanga protocol, involving gentle massage using warm oil applied to the lower limbs for a specified duration, administered by trained therapists under the supervision of AYUSH Medical officer. The frequency and duration of abhyanga sessions will be outlined in the protocol.
Duration- 3 months |
| Comparator Agent |
standard treatment of RLS |
The control group will receive standard care for restless leg syndrome. Pregabalin, gabapentins
dopaminergic agonists- Ropinirole, pramipexole
SOS- levodopa
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Geriatric patients (55 years and above) diagnosed with restless leg syndrome.
2. Patient diagnosed to have RLS through- International RLS Study Group (IRLSSG) diagnostic criteria)
3. Willingness to participate and provide informed consent.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Restless leg syndrome symptom severity assessed using International Restless Legs Syndrome Study Group (IRLSSG) rating scale |
baseline, 1 month, 2 month, 3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. sleep quality through PSQI
2. mental health through GDS |
0 and 12 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
04/02/2026 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
This RCT aims to evaluate the effectiveness of a structured integrative medicine lifestyle approach, including ayurvedic therapies like abhyanga and yoga as an adjunct to standard treatment in elderly patients with restless leg syndrome. conducted at AIIMS Rishikesh the study will enrol 30 participants in each arm, diagnosed to have RLS using IRLSSG criteria. the primary objective is to assess the reduction in RLS symptom severity while secondary outcomes include improvements in sleep quality nd mental health. participants will be randomly assigned to either the intervention or control group. the study aims to provide insights into a cost effective, patient friendly alternative for managing RLS symptoms in the elderly population |