| CTRI Number |
CTRI/2024/03/064455 [Registered on: 19/03/2024] Trial Registered Prospectively |
| Last Modified On: |
01/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Press Kukundara Marma situated in low back region for the treatment of low back pain(Katishoola) |
|
Scientific Title of Study
|
An Anatomical Study on Kukundara Marma with special reference to Katishoola (Low Back Pain) |
| 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 Ragini devi pal |
| Designation |
MD Scholar |
| Affiliation |
Institute of Medical Science BHU |
| Address |
Department of Rachana Sharir Faculty of Ayurveda IMS BHU Varanasi Uttar Pradesh
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7800528806 |
| Fax |
|
| Email |
raginipal1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ragini devi pal |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical Science BHU |
| Address |
Department of Rachana Sharir Faculty of Ayurveda IMS BHU Varanasi Uttar Pradesh
UTTAR PRADESH
221005
India |
| Phone |
7800528806 |
| Fax |
|
| Email |
raginipal1996@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Vijay laxmi Gautam |
| Designation |
Professor |
| Affiliation |
Institute of Medical Science BHU |
| Address |
Department of Rachana Sharir Faculty of Ayurveda IMS BHU Varanasi Uttar Pradesh
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9451440263 |
| Fax |
|
| Email |
vlaxmi40@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Sunderlal Hospital BHU Varanasi OPD No 16C |
|
|
Primary Sponsor
|
| Name |
Institute of Medical Science |
| Address |
Institute of Medical Science Banaras Hindu University Varanasi 221005 |
| Type of Sponsor |
Government 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 Ragini Devi Pal |
Sir Sundarlal Hospital |
Department of Panchkarma OPD No. 16C Indian Medicine Wing Varanasi Uttar Pradesh
Varanasi
UTTAR PRADESH |
7800528806
raginipal1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M479||Spondylosis, unspecified. Ayurveda Condition: VATAJASULAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Tryodashanga guggula and Dashmula kwath, Reference: Bhaishajya ratnawali, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - | | 2 | Intervention Arm | Procedure | - | marmacikitsA, मरà¥à¤®à¤šà¤¿à¤•à¤¿à¤¤à¥à¤¸à¤¾ | (Procedure Reference: Sushrut Sharir 6 chapter, Procedure details: stimulation of kukundara marma 12 to 15 times per minutes(for 3 minute) twice daily for 10 days
)
(1) Medicine Name: Tryodashanga gugglu and Dashmula kwath, Reference: Bhaishajya ratnawali, Route: Oral, Dosage Form: Guggulu, Dose: 500(mg), Frequency: bd, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
clinical symptoms with or without radiological changes. |
|
| ExclusionCriteria |
| Details |
1. Patients below 20 years and above 70 years of age will be excluded.
2. Patient suffering from paralysis.
3. Uncontrolled diabetes mellitus, cardiovascular disease, neoplastic disorder, any severe illness.
4. Pregnancy
5. Severe malnourished, debilitated
6. Myelopathy, any type of malignancy |
|
|
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 |
Relief in sign and symptoms of the disease. The main sign and symptoms in the study are as follow
Pain in Kati(lumbar region)
Stiffness in Kati
Numbness
Tingling sensation
Headache
Weakness of lower limbs
Giddiness
|
30 days study with follow up at 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
education in scoring of following scale;
Visual Analog Scale |
30 days study with follow up at 15 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/04/2024 |
| 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 Applicable |
| 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
|
50 cases of Katishoola (Low Back Pain) will be included in this interventional study which will be randomly divided in to two groups of 25 patients in each group. One group will be prescribed Tryodashanga Guggulu and Dashmoola Kwath. Second group will be prescribed Tryodashanga Guggulu, Dashmoola Kwath and Kukundara Marma Chikitsa. |