| CTRI Number |
CTRI/2020/03/024225 [Registered on: 24/03/2020] Trial Registered Prospectively |
| Last Modified On: |
18/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Difference Between the effect of Rasona Ksheerpaka and Lashuna Yoga in management of
Gridhrasi. |
|
Scientific Title of Study
|
Comparative Study To Evaluate The Effectiveness of Rasona Ksheerpaka and Lashuna Yoga in management of Gridhrasi |
| Trial Acronym |
CSEERLG |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Atal Bihari Trivedi |
| Designation |
Associate Professor |
| Affiliation |
Choudhary Brahm Prakash Ayurved Charak Sansthan, |
| Address |
Room no 148, Ist Floor, Department of Kayachikitsa,Choudhary Brahm Prakash Ayurved Charak Sansthan,Khera Dabar,Najafgarh,New Delhi-110073
Housing block D,room no. D-8,Choudhary Brahm Prakash Ayurved Charak Sansthan,Khera Dabar,Najafgarh,New Delhi-110073
South West
DELHI
110073
India |
| Phone |
9958046550 |
| Fax |
|
| Email |
abdratal8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atal Bihari Trivedi |
| Designation |
Associate Professor |
| Affiliation |
Choudhary Brahm Prakash Ayurved Charak Sansthan, |
| Address |
Room no 148, Ist Floor, Department of Kayachikitsa,Choudhary Brahm Prakash Ayurved Charak Sansthan,Khera Dabar,Najafgarh,New Delh
Housing block D,room no.D-8,Choudhary Brahm Prakash Ayurved Charak Sansthan,Khera Dabar,Najafgarh,New Delhi-110073
South West
DELHI
110073
India |
| Phone |
9958046550 |
| Fax |
|
| Email |
abdratal8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kamini Baudh |
| Designation |
PG Scholer |
| Affiliation |
Choudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Department of Kayachikitsa,Choudhary Brahm Prakash Ayurved Charak Sansthan,Khera Dabar,Najafgarh,New Delhi-110073
PG girls hostel ,Choudhary Brahm Prakash Ayurved Charak Sansthan,Khera Dabar,Najafgarh,New Delhi-110073
South West
DELHI
110073
India |
| Phone |
8377030590 |
| Fax |
|
| Email |
kamini.baudh1993@gmail.com |
|
|
Source of Monetary or Material Support
|
| Choudhary Brahm Prakash Ayurved Charak Sansthan,Khera Dabar,Najafgarh,New Delhi |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 |
| Kamini baudh |
Choudhary Brahm Praksh Ayurved Charak Sansthan |
OPD no.2 OF kayachikitsa ,Khera Dabar,New Delhi
South West
DELHI |
8377030590
kamini.baudh1993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC -CBPACS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G570||Lesion of sciatic nerve, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lashuna Yoga |
30 Patients will be given Lashuna Yoga
Ingredients- Lashuna(Allium Sativum) and Ghrita.
Preparation- Lashuna Kalka about one karsh (12g) with twice amount of Ghrita after meal in two equal doses |
| Comparator Agent |
Rasona Ksheerpaka |
30 Patients will be given Rasona Ksheerpaka
Ingredients- Rasona(Allium Sativum),Milk,Water.
Preparation-Rasona(6g) milk(100ml) water(100ml)then boiled it and reduced it 100ml ,then take it twice a day after meal. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having clinical features of Gridhrasi.
Chronicity more than 3 month.
patients should full fill SLR positive 30-70.
VAS score 3-8
Oswestry disability index 21-80% |
|
| ExclusionCriteria |
| Details |
Patients with back pain associated with traumatic injury to spine,inflammatory arthritis,monoplagia, paraplegia, and cauda equina syndrome.
Pregnant and lactating women.
patients having other complications including major bony deformity.
patients having associated cardiac desease,tuberculosis,malignant hypertension, impairement of liver functions, malignanacy,HIV AIDS,GI Disorder etc |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Stambha(Stiffness)
ruk(pain)
Spandate muhu(pulsatile pain)
Toda(pricking sensation)
Tandra(Drowsiness)
Gaurav(Heavyness)
Arochaka(loss of appetite) |
DAY 1
DAY 7
DAY 14
DAY 21
DAY 21
DAY 45 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Straight leg raising test
Visual Analogue scale
Oswestry disability index
Bragard test |
DAY1
DAY 7
DAY 14
DAY 21
DAY 28
DAY 45 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
27/03/2020 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This trial is conducting for the purpose of MD dissertation award. Gridhrasi is cited in different ancient indian medical literature. In Charak samhita chikitsa sthan chapter 28 named vatavyadhi chikitsa adhyaya ,Acharaya Charak has mentioned this disease along with other vatavyadhis .He has mentioned common etiological factors for all the vatavyadhis as inappropriate and excessive excercises swimming, jumping, excessive walking, trauma,falling from different vehicle etc.Symptoms of this disease are pain, stiffness,pricking or pulsatile sensation starting from gluteal region than radiiating to waist, back, thigh, lower leg and foot.Different other Acharyas has also opined same as acharaya charak regarding the symptoms and etiology of this disease. The main objective of study is to evaluate the effect of Lashuna Yoga in the management of Gridhrasi. Do and Don’ts- The patient is instructed in back strenghthening excercises. The patient is advised to avoid physical manoeuveres likely to strain the lumbar spine. |