| CTRI Number |
CTRI/2025/08/093392 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing Ayurvedic and Swedish Massage technique with Aromatic versus Non-Aromatic Oils in Non-Traumatic Low Back Pain |
|
Scientific Title of Study
|
Evaluation of comparative efficacy of two Massage techniques (Ayurvedic versus
Swedish) by using Aromatic versus Non-Aromatic Oils in the management of Non-Traumatic Low Back Pain: A Randomized Four-Arm Parallel 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 Samruddhi Anil Walke |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha Maharashtra India 442001 |
| Address |
Room no. 40, Department of Panchkarma Mahatma Gandhi Ayurveda College
Hospital and Research Center, Hirapur Salod, Wardha
MAHARASHTRA
Wardha
MAHARASHTRA
442001
India |
| Phone |
8999746371 |
| Fax |
|
| Email |
walkesamruddhi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Samruddhi Anil Walke |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha Maharashtra India 442001 |
| Address |
Room no. 40, Department of Panchkarma Mahatma Gandhi Ayurveda College
Hospital and Research Center, Hirapur Salod, Wardha
MAHARASHTRA
Wardha
MAHARASHTRA
442001
India |
| Phone |
8999746371 |
| Fax |
|
| Email |
walkesamruddhi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Punam Sawarkar |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha Maharashtra India 442001 |
| Address |
Room no. 40, Department of Panchkarma Mahatma Gandhi Ayurveda College
Hospital and Research Center, Hirapur Salod, Wardha
MAHARASHTRA
Wardha
MAHARASHTRA
442001
India |
| Phone |
9860667023 |
| Fax |
|
| Email |
drsuple.punam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College Hospital and Research Centre, Salod, Hirapur, Wardha
Maharashtra India 442001
|
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurved College Hospital and Research Centre |
| Address |
Room no 40 Department of Panchakarma Mahatma Gandhi Ayurved
College Hospital and Research Centre Salod Hirapur Wardha
Maharashtra India 442001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Punam Sawarkar |
Mahatma Gandhi Ayurved College Hospital and Research Centre |
Room no. 40, Department of Panchkarma Mahatma Gandhi Ayurveda College
Hospital and Research Center, Hirapur Salod, Wardha
Wardha
MAHARASHTRA
Wardha
MAHARASHTRA |
9860667023
drsuple.punam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurved College Hospital And Research Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M545||Low back pain. Ayurveda Condition: ASTHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Snehana | Modern (Swedish massage) with simple Devdaru oil with 10 ml | | 2 | Comparator Arm (Non Ayurveda) | | - | Snehana | Modern (Swedish Massage) Aromatic essential Devdaru oil with 10 ml | | 3 | Intervention Arm | Procedure | - | Snehana | (Procedure Reference: Charak Samhita , Procedure details: Traditional massage with Aromatic essential Devdaru oil with 10 ml for 10 days)
(1) Medicine Name: Aromatic essential Devdaru oil , Reference: Sushruta Samhita , Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 10 Days | | 4 | Intervention Arm | Procedure | - | Snehana | (Procedure Reference: Charak Samhita , Procedure details: Traditional massage with simple Devdaru oil for 10 days with 10 ml simple Devdaru oil ))
(1) Medicine Name: simple Devdaru oil, Reference: Dhanvantari Nighantu , Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 10 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to give written informed consent and of either gender between the ages of 20 and 60 years.
Patients with non-traumatic Muscular LBP having acute (up to 12 weeks) or Chronic (up to 3 months)
low back pain
Patient able to attend sessions and follow up regularly.
Patient indicated for massage/abhyang with simple oil and aromatic oil. |
|
| ExclusionCriteria |
| Details |
Patients with LBP but suffering from Trauma, Fractures , hemi/paraparesis, infections Inflammatory
diseases, menstruation, and PID.
History of spinal surgery
Pregnant and lactating women
with Neurological deficits |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the efficacy of two Massage techniques (Ayurvedic versus Swedish) by using Aromatic versus Non-Aromatic Oils in the management of Non-Traumatic Low Back Pain: A Randomized Four-Arm Parallel Clinical Trial |
at baseline, 20 days and 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison and Assessment of the Efficacy of two Massage techniques (Ayurvedic versus Swedish) by using Aromatic versus Non-Aromatic Oils in the management of Non-Traumatic Low Back Pain: A Randomized Four-Arm Parallel Clinical Trial |
at baseline, 2 weeks 6 days and 4 weeks 2 days |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
17/09/2025 |
| 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="2"
Months="0"
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
|
The volunteers will be informed about the study protocol. Willing participants will be randomly selected as per the computer-generated table. The clinical research format will be prepared and validated. Prior to the study, approval will be taken from IEC, MGACHRC, Salod (H), and Wardha, and CTRI registration will be done. After selection, each participant will be tested individually and selected according to selection criteria. They are divided into two groups. The trial is a randomized, open-labeled, standard-controlled equivalence clinical trial. It will include a 30-day treatment period and a follow-up period on the 20th and 30th days and an assessment period on the 0th, 10th, 20th, and 30th days. |