| CTRI Number |
CTRI/2021/12/038443 [Registered on: 06/12/2021] Trial Registered Prospectively |
| Last Modified On: |
02/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
" The effect of Katibasti with Moolaka tailm in the management of Kati garha(lumber spondylosis)" |
|
Scientific Title of Study
|
"A clinical study to evaluate the effect of Katibasti with Moolaka tailm the management of Kati garha(lumber spondylosis)" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha pal |
| Designation |
Post graduation scholar |
| Affiliation |
Shubhdeep Ayurved Medical College |
| Address |
Shubhdeep Ayurved Medical College Datoda Indore
Indore
MADHYA PRADESH
452020
India |
| Phone |
6307612988 |
| Fax |
|
| Email |
npal3223@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAKsingh |
| Designation |
professor |
| Affiliation |
Shubhdeep Ayurved Medical College |
| Address |
Shubhdeep Ayurved Medical College Datoda Indore
Indore
MADHYA PRADESH
452020
India |
| Phone |
9300681233 |
| Fax |
|
| Email |
doctoraksingh@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAKsingh |
| Designation |
professor |
| Affiliation |
Shubhdeep Ayurved Medical College |
| Address |
Shubhdeep Ayurved Medical College Datoda Indore
Indore
MADHYA PRADESH
452020
India |
| Phone |
9300681233 |
| Fax |
|
| Email |
doctoraksingh@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Shubhdeep Ayurved Medical College Datoda Indore MP pincode 452020 |
|
|
Primary Sponsor
|
| Name |
Shubhdeep Ayurved Medical College |
| Address |
Shubhdeep Ayurved Medical College Datoda Indore |
| Type of Sponsor |
Private 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 Neha pal |
shubhdeep ayurved medical college |
Panchkarma OPD room no. 7,shubhdeep ayurved medical college datoda indore 452020
Indore
MADHYA PRADESH |
6307612988
npal3223@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Shubhdeep Ayurved Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M470||Anterior spinal and vertebral artery compression syndromes. Ayurveda Condition: kati garha, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | kaTibastiH, कटिबसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Yadaiah P, Kati basti a practical Approach. National Journal of Ayurveda, March 1995; 5:2-3. , Procedure details: 1.Prepration of Mashpishti and Sthanika Abhyanga.
2. Katibasti with lukewarm Moolaka taila 200ml.(30min)for 14days.
3.The part will be cleaned with the help of lukewarm water.)
(1) Medicine Name: Moolaka taila, Reference: Charak samhita edited by Pt. Kashinatha sastri,Dr.Gorakhanatha chaturvedi,chikitsasthan 28 shlok -136,137, Route: Topical, Dosage Form: Taila, Dose: 200(ml), Frequency: od, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient will be selected fuifill the criteria of Katigarha symptoms as Katisoola,Sakthi Ruja,Supti.
2.Age between 16 to 70 year.
3.Patient willing to participate in tiral.(consent duly filled) |
|
| ExclusionCriteria |
| Details |
1.Chronicity for more than 10 years.
2.Having severe crippling deformity.
3.Patient suffering with Cardiac diseases,pulmonary tuberculosis diabetes mellitus.
4.Patients below 16 and above 70 years |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in classical sign and symptoms of kati garha(At the time of baseline and at the end of the treatment 3 weeks) |
Change in classical sign and symptoms of kati garha(At the time of baseline and at the end of the treatment 3 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of change in the clinical parameters |
Total study period 12 months and trearment period 14 days |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
10/12/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet publised |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study of randomized interventional clinical study of kati basti with moolaka tailm in kati garha (lumber spondylosis). Total 30 patients will be enrolled in present study. selected patients will be in signle group on the basis of computer generated randomization |