CTRI Number |
CTRI/2022/01/039142 [Registered on: 04/01/2022] Trial Registered Prospectively |
Last Modified On: |
04/01/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Medical Device Ayurveda Yoga & Naturopathy |
Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
|
Comparison between Marma therapy and Kati basti in low back pain treatment |
Scientific Title of Study
|
An Anatomical study on Katikataruna Marma and its clinical application in comparison to Kati Basti on Katisula (Low back pain) |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Anurag Tiwari |
Designation |
MD Scholar |
Affiliation |
Faculty of Ayurved , IMS-BHU |
Address |
Department Of Rachana Sharir
Faculty of Ayurveda
IMS-BHU
Varanasi UTTAR PRADESH 221005 India |
Phone |
8874388783 |
Fax |
|
Email |
anurag7236@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Prof Vijay Laxmi Gautam |
Designation |
Professor |
Affiliation |
Faculty of Ayurved , IMS-BHU |
Address |
Dept. of Rachana Sharir
Faculty of ayurveda
Ims,Bhu
Varanasi UTTAR PRADESH 221005 India |
Phone |
|
Fax |
|
Email |
vlaxmi40@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Anurag Tiwari |
Designation |
MD Scholar |
Affiliation |
Faculty of Ayurved , IMS-BHU |
Address |
Department of Rachana Sharir
Faculty of Ayurveda
IMS-BHU
Varanasi UTTAR PRADESH 221005 India |
Phone |
|
Fax |
|
Email |
anurag7236@gmail.com |
|
Source of Monetary or Material Support
|
Department of Rachana sharir IMS, BHU |
|
Primary Sponsor
|
Name |
Anurag Tiwari |
Address |
Dept. of Rachana Sharir , Faculty of ayurveda , IMS , BHU, Varanasi |
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 |
Anurag Tiwari |
Sir Sundarlal Hospital , IMS BHU |
Sir Sundarlal Hospital
Opd 16 C
Ayurveda Wing ,
institute of medical sciences, BHU , varanasi, up Varanasi UTTAR PRADESH |
8874388783
anurag7236@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institute Ethics committee |
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: KATISHULA, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | marmacikitsA, मरà¥à¤®à¤šà¤¿à¤•ितà¥à¤¸à¤¾ | (Procedure Reference: Sushruta sharir sthan chapter 6, Procedure details: katikataruna marma chikita 16-18 times per minute for 5 minute twice daily) (1) Medicine Name: Tryodasang gugglu with dasmool kwath, Reference: Bhaisjyaratnawali, Route: Oral, Dosage Form: Guggulu, Dose: 1(g), Frequency: bd, Duration: 2 Months | 2 | Intervention Arm | Procedure | - | kaTibastiH, कटिबसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Panchkarma, Procedure details: Kati Basti with Mahanarayan taila (one time per day continuous for seven days for each month) .) (1) Medicine Name: Tryodasang guggulu with dasmool kwath, Reference: Bhaisjyaratnawali, Route: Oral, Dosage Form: Guggulu, Dose: 1(g), Frequency: bd, Duration: 2 Months | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Tryodasang Guggulu, Reference: Bhaisjyaratnawali, Route: Oral, Dosage Form: Guggulu , Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Dasmool kwath), Additional Information: |
|
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Clinical symptoms of low back pain with or without radiological changes. |
|
ExclusionCriteria |
Details |
1. Patients below 20 years and above 60 years of age will be excluded.
2. Patient suffering from paralysis.
3. Uncontrolled diabetes mellitus, cardiovascular disease, neoplastic disorders.
4. Pregnancy
• Severely malnourished, debilitated
• Myelopathy
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Alternation |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Pain in low back is studied |
At duration of 30 days, 60 days. |
|
Secondary Outcome
|
Outcome |
TimePoints |
Stiffness in low back , numbness and weakness of lower limb are studied. |
At duration of 30 days , 60 days. |
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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
|
N/A |
Date of First Enrollment (India)
|
05/01/2022 |
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="2" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Comparative study between ayurvedic medicine treatment , marma therapy treatment and kati basti treatment of Katishula is done |