| CTRI Number |
CTRI/2026/03/106247 [Registered on: 16/03/2026] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
New Temperature Controlled Ayurvedic Therapy Device Versus Traditional Manya Basti in Manyashoola Patients |
|
Scientific Title of Study
|
Evaluation of comparative efficacy of newly developed thermoregulated automated irrigation device conceptualized from ashtanga hridaya principles as against traditional method in manyashoola patients a 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 |
Monika Luharia |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research (Deemed to be University) |
| Address |
Department of Samhita & Siddhant
Mahatma Gandhi College of Ayurveda
Sawangi (Meghe), Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9834444164 |
| Fax |
|
| Email |
monikaluharia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Rushikesh Thakare |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research (Deemed to be University) |
| Address |
Department of Samhita & Siddhant
Mahatma Gandhi College of Ayurveda
Sawangi (Meghe), Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9765404039 |
| Fax |
|
| Email |
dr.rushu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Monika Luharia |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research (Deemed to be University) |
| Address |
Department of Samhita & Siddhant
Mahatma Gandhi College of Ayurveda
Sawangi (Meghe), Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9834444164 |
| Fax |
|
| Email |
monikaluharia@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Monika Luharia |
| Address |
Department of Samhita and Siddhant
Mahatma Gandhi College of Ayurveda
Datta Meghe Institute of Higher Education and Research Sawangi Wardha 442001 Maharashtra India
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| datta meghe institute of higher education and research |
sawangi wardha 442001 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Monika Luharia |
Mahatma Gandhi Ayurved College Hospital and Research Centre |
Department of Samhita & Siddhant, Mahatma Gandhi Ayurved College Hospital and Research Centre, Datta Meghe Institute of Higher Education and Research (Deemed to be University), Sawangi (Meghe), Wardha, Maharashtra – 442001, India
Wardha
MAHARASHTRA |
9834444164
monikaluharia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: MANYASTAMBAH (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Thermoregulated Automated Irrigation Device for Manya Basti | (Procedure Reference: Conceptualized from principles described in Ashtanga Hṛdaya for Manya Basti procedure., Procedure details: Manya Basti performed using a thermoregulated automated irrigation device to maintain controlled temperature of medicated oil over the cervical region in patients with Manyashoola.)
(1) Medicine Name: Dashmoola Oil, Reference: Bhaishajya Ratnavali, Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | Traditional Manya Basti | (Procedure Reference: Ashtanga Hṛdaya, Procedure details: Traditional method of Manya Basti using dough ring (Masha or wheat flour) placed over cervical region followed by retention of warm medicated oil in patients with Manyashoola.)
(1) Medicine Name: Dashmool Oil, Reference: Bhaishajya Ratnavali, Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to participate in trial with written informed consent.
Pateints of Neck pain intensity greater or equal to 4 on the Visual Analog Scale.
Patients aged between 30 to 60 years.
Patients irrespective of religion, gender or socio economic status
|
|
| ExclusionCriteria |
| Details |
Patients of Recent neck surgery.
Patients with age group below 30 and above 60 years.
Patient diagnosed with disease like rheumatoid arthritis TB of bones local infection or any life threatening conditions and trauma.
Pregnant and lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in severity of Manyashoola (neck pain)
Improvement in cervical range of motion in patients with Manyashoola. |
Baseline (Day 0), Day 7 (end of treatment), and Day 14 (follow-up) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in neck stiffness Manyastambha
Reduction in local tenderness in the cervical region
Improvement in functional ability of the cervical region
Improvement in cervical range of motion |
Assessed at baseline
Week 4 & Week 8 |
|
|
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 2 |
|
Date of First Enrollment (India)
|
01/04/2026 |
| 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="6"
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
|
It is a two phase randomized control trial where in phase one we are going to design and devlope the thermoregulated automated irrigation device and in second phase we will be enrolling the patients after CTRI approval in order to prove the multiple efficiancy of newly devloped device against the tradiational method of greeva basti in the management of manya shula patient |