| CTRI Number |
CTRI/2025/03/082000 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical study to assess the effect of kati basti and matra basti with Rasna taila and Ketakimooladi taila in the management of low back pain |
|
Scientific Title of Study
|
An open labelled randomized comparative clinical study to evaluate the efficacy of kati basti and matra basti with rasna taila and ketakimooladi taila in the management of katigraha vis-a-vis lumbar spondylosis |
| 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 Sampada I Kajagar |
| Designation |
PG Scholar |
| Affiliation |
JSS Ayurveda Medical College |
| Address |
JSS Ayurvedic Medical College And Hospital 41/E
Lalithadripura Road Mysuru
Karnataka 570028
Mysore
KARNATAKA
570028
India |
| Phone |
8660472138 |
| Fax |
|
| Email |
sampadaik99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena G Rao |
| Designation |
professor and HOD |
| Affiliation |
JSS Ayurveda medical college and hospital |
| Address |
JSS Ayurvedic Medical College And Hospital 41/E
Lalithadripura Road Mysuru
Karnataka 570028
Mysore
KARNATAKA
570028
India |
| Phone |
9844549152 |
| Fax |
|
| Email |
drveenagrao@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Veena G Rao |
| Designation |
professor and HOD |
| Affiliation |
JSS Ayurveda medical college and hospital |
| Address |
JSS Ayurvedic Medical College And Hospital 41/E
Lalithadripura Road Mysuru
Karnataka 570028
Mysore
KARNATAKA
570028
India |
| Phone |
9844549152 |
| Fax |
|
| Email |
drveenagrao@yahoo.in |
|
|
Source of Monetary or Material Support
|
| JSS ayurveda medical hospital
41/E Lalithadripura road Mysuru Karnataka 570028 |
|
|
Primary Sponsor
|
| Name |
Dr Sampada I Kajagar |
| Address |
JSS Ayurvedic Medical College And Hospital 41/E Lalithadripura Road
Mysuru Karnataka 570028 |
| 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 Sampada I Kajagar |
JSS Ayurveda Medical College and Hospital |
Panchakarma OPD No-2,
41/E, Lalithadripura road, Mysuru,Karnataka-570028
Mysore
KARNATAKA |
8660472138
sampadaik99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Clearance Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M478||Other spondylosis. Ayurveda Condition: VATAVYADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Charaka siddhi 4/53, Procedure details: Kati basti with Ketakimooladi taila will be performed locally on lumbosacral region, once daily for 10 days. Matra basti with Ketakimooladi taila in the dose of 75ml once in a day by anal route will be administered for 7 days.)
(1) Medicine Name: Ketakimooladi taila, Reference: Gada nigraha vatarogadhikara 19/151-152, Route: Rectal, Dosage Form: Taila, Dose: 75(ml), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Charaka siddhi 4/53, Procedure details: Kati basti with Rasna taila will be performed locally on lumbosacral region, once daily for 10 days. Matra basti with Rasna taila in the dose of 75ml once in a day by anal route will be administered for 7 days.)
(1) Medicine Name: Rasna taila, Reference: Charaka chikitsa 28/165-166, Route: Rectal, Dosage Form: Taila, Dose: 75(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects of age group between 30-70 years of either gender
Subjects having signs and symptoms of Katigraha(Lumbar Spondylosis) such as stiffness and pain at low back region
Subjects fit for Kati Basti and Matra Basti
|
|
| ExclusionCriteria |
| Details |
Subjects with major systemic diseases that may interfere with the course of treatment like vascular, liver, cardiac disorders, coagulopathies etc
Disc prolapse, traumatic, infective and neoplastic conditions of lumbar spine
Subjects linked to both simple and complicated fractures
Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the combined effect of kati basti and matra basti with Rasna taila and Ketakimooladi taila in the management of Katigraha vis-a-vis Lumbar spondylosis |
Treatment will be given for 10 days. Patients will be assessed on 0,3rd and 11th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the combined effect of kati basti and matra basti with Rasna taila in the management of Katigraha vis-a-vis Lumbar spondylosis
To evaluate the combined effect of kati basti and matra basti with Ketakimooladi taila in the management of Katigraha vis-a-vis Lumbar spondylosis |
Pre test-0 day
3rd day-Post koshta Shodhana
Post test-11th day |
|
|
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)
|
20/03/2025 |
| 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="1"
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
|
Katigraha is a condition in which the vitiated Vata localizes in the Kati Pradesha producing Shula and Stabdhata i.e. restricted mobility of low back region. Stressful life, workouts, ageing, frequent travelling, improper postural habits will lead to one of the most common clinical health problem of low back ache which hampers the day-to-day activities. Low back pain is more prevalent among the middle-aged and elderly, which affects both genders equally. The prevalence rate affecting adults is approximately 60-80% at some time in their lives (1). Lumbar Spondylosis is a degenerative condition which affects the discs, vertebral bodies and/or associated joints of lumbar spine (2) which can be corelated to Katigraha due to similarity in clinical manifestation and pathogenesis. In Lumbar Spondylosis, back pain is usually in the lumbosacral area and the back of the thighs. Patients often complain of spinal stiffness, paraspinal muscle spasm and difficulty in performing activities of daily living. In modern medicine, if the disease is in early stage it is managed by medications such as analgesics and anti-inflammatory drugs, muscle relaxants, corticosteroids, epidural steroid injections etc. but these drugs cannot be used for longer duration. Acharya Charaka has mentioned Snehana, Swedana and Basti as general line of treatment for Vata Vyadhis (3). Kati Basti is a Bahir Parimarjana Chikitsa (4) and Matra Basti (5) is a type of Sneha Basti which is indicated in Vata Vikaras. Katigraha, as it is a degenerative condition comparison is made between Rasna Taila having Vatahara due to the virtue of Shulahara property being compared with Ketakimooladi Taila having Vatahara due to its Balya and Brimhana property; in the form of both Kati Basti and Matra Basti respectively. Thus, this study is intended in relieving pain and stiffness in low back region by comparing the effects of Rasna Taila and Ketakimooladi Taila. Hence, a comparative clinical study has been taken up to evaluate the therapeutic effect of Kati Basti and Matra Basti using Rasna Taila and Ketakimooladi Taila in the management of Katigraha vis-à vis Lumbar Spondylosis. |