| CTRI Number |
CTRI/2025/04/083863 [Registered on: 02/04/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to evaluate the efficacy of medicated oil gauze in stiffness of low back. |
|
Scientific Title of Study
|
Open label single arm clinical study to evaluate the efficacy of Prishta Pichu with Prasarini Taila in Kati Graha. |
| 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 PrajnaRao G |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital |
| Address |
Department of Panchakarma
Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital
Thanniruhalla
Hassan
Karnataka
India
Hassan KARNATAKA 573201 India |
| Phone |
9945888328 |
| Fax |
|
| Email |
prajnaraog@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ashvini Kumar M |
| Designation |
Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital |
| Address |
Department of Panchakarma
Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital
Thanniruhalla
Hassan
Karnataka
India
Hassan KARNATAKA 573201 India |
| Phone |
9448705660 |
| Fax |
|
| Email |
ashvinipanchakarma@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ashvini Kumar M |
| Designation |
Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital |
| Address |
Department of Panchakarma
Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital
Thanniruhalla
Hassan
Karnataka
India
Hassan KARNATAKA 573201 India |
| Phone |
9448705660 |
| Fax |
|
| Email |
ashvinipanchakarma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital
Thanniruhalla
Hassan
Karnataka
India
573201 |
|
|
Primary Sponsor
|
| Name |
Dr Prajnarao G |
| Address |
Department of Panchakarma
Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital
Thanniruhalla
Hassan
Karnataka
India
573201 |
| 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 PrajnaRao G |
Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital |
OPD and IPD under all departments of Sri Dharmasthala Manjunatheshwara Ayurveda College & Hospital, Thanirruhalla, Hassan, Karnataka, India 573201 Hassan KARNATAKA |
9945888328
prajnaraog@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M519||Unspecified thoracic, thoracolumbar and lumbosacral intervertebral disc disorder. Ayurveda Condition: PRUSHTHA-GRAHAHÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Pristha Pichu | (Procedure Reference: Astanga Hridaya Sutrasthanam 22, Procedure details: Prasarini Taila is heated till 38-42 degree Celsius in double boil method. The prepared cotton pads are dipped into the heated oil and is placed over Prishta Pradesha, that is superiorly extending from atlas i.e first cervical vertebrae covering gluteal region inferiorly, laterally extending upto mid axillary line on either side.
Once the heated oil cools down, the cotton pads are removed and then immersed in
warm oil and are placed over prishta pradesha.
This procedure is repeated for 30 minutes or till Samyak svinna lakshanas are attained with a replacement of oil when it gets cooled down.) (1) Medicine Name: Prasarini Taila , Reference: Sharangdhara Samhita , Route: Topical, Dosage Form: Taila, Dose: 0(NA), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants with low back pain, tenderness at kati pradesha, stiffness and reduced range of movements of kati pradesha.
2. Participants between the age of 20-60 years irrespective of gender.
3. Participants who are willing to participate and sign the informed consent form. |
|
| ExclusionCriteria |
| Details |
1. Participants presenting with the history of traumatic, infective and neoplastic conditions
of spine.
2. Diagnosed cases of HIV, HBsAG, Tuberculosis,
3. Pregnant women.
4. Participants presenting with the history of major systemic disorders that may interfere
with the course of treatment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment will be based on Katishoola (Visual analogue scale 0-10), Stambha (Schober’s test), Kriyahani (flexion), Tenderness, Samyak svedana lakshana. |
0th,7th and 22nd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To improve ease of life. |
22nd day |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
28/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/04/2025 |
| 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 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
|
In today’s fast-paced era of modernization, we are seeing
lifestyle shifts like excessive mobile and computer usage, prolonged sitting
with poor posture, long periods of uninterrupted work, and extensive travel.
These habits can put undue pressure on the spine and increase the risk of
injury. Low back pain is a common health issue that affects millions of people
worldwide. The recent prevalence rates of low back pain show point prevalence
is approximately 48%, annual prevalence is approximately 51%, lifetime
prevalence is approximately 66%. Katigraha is an important clinical, social,
economic and public health problem affecting the population. It falls within
the spectrum of Vataja Nanatmaja Vyadhis, characterized by pain and stiffness
in the Kati Pradesha. Spine is a single entity which is made up of 33
vertebrae, 23 intervertebral discs, various muscles, ligaments and connective
tissues. The intrinsic muscles such as erector spinae group of muscles and
ligaments such as anterior and posterior longitudinal ligaments run throughout
the length of spine. The spine’s integrity depends significantly on the
strength, flexibility, and coordination of the back muscles. The local kati
basti or kati pichu treatments target only a small portion of the spine, covering
approximately 10-15% of the back region. Whereas the proposed prishta pichu
therapy offers an aid in comprehensive strengthening of the spine by addressing
the entire spine and back area. Although Prishta pichu is practised, there is
no sufficient research has been done on this procedure. Thus, for current
study, Prishta pichu is taken in kati graha cases to know its clinical
efficacy. |