CTRI Number |
CTRI/2018/01/011098 [Registered on: 02/01/2018] Trial Registered Retrospectively |
Last Modified On: |
29/03/2018 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
To Compare Effect Of Two Basti (Medicated Enema)With Some Herbal Drug In The Management Of Sciatica |
Scientific Title of Study
|
A comparative clinical study on the effect of Ksheerbala Taila Matra Basti and Erandmooladi Yoga Basti followed by Rasna Guggulu in the management of Gridhrasi(Sciatica) |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Gopesh Mangal |
Designation |
Assistant proffesor |
Affiliation |
National Institute of Ayurveda |
Address |
I/C HOD P G Department of panchkarma National Institute of Ayurveda
jorawar singh gate
Jaipur RAJASTHAN 302002 India |
Phone |
8619849011 |
Fax |
|
Email |
Gmangal108@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Gopesh Mangal |
Designation |
Assistant proffesor |
Affiliation |
National Institute of Ayurveda |
Address |
I/C HOD P G Department of panchkarma National Institute of Ayurveda
jorawar singh gate
Jaipur RAJASTHAN 302002 India |
Phone |
8619849011 |
Fax |
|
Email |
Gmangal108@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr kapil sharma |
Designation |
M D Scholar |
Affiliation |
National Institute of Ayurveda |
Address |
P G Department of panchkarma
National Institute of Ayurveda
jorawar singh gate
Jaipur RAJASTHAN 302002 India |
Phone |
9462201066 |
Fax |
|
Email |
sharma.kapil0608@gmail.com |
|
Source of Monetary or Material Support
|
National Institute of Ayurveda jaipur |
|
Primary Sponsor
|
Name |
National Institute of Ayurveda |
Address |
Madhav vilas palace Jorawar singh gate Amer road jaipur |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
Name |
Address |
Dr Gopesh mangal |
P G Department of panchkarma national institute of Ayurveda jaipur |
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Gopesh mangal |
National Institute Oof Ayurveda |
department of panchakarma near jorawar singh gate madhav vilas jaipur Jaipur RAJASTHAN |
8619849011
Gmangal108@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF AYURVEDA |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Gridhrasi (Sciatica), |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Panchasakar Churna with Erandmooladi Niruha Basti with Rasna Guggulu
|
Anulomana with Panchasakar Churana 5 grams for first two days followed by Erandmooladi Niruha Basti in Yoga Basti schedule (8 days)followed by Rasna Guggulu 1 gram (500mg each tablet)three times a day for 30days
|
Intervention |
Panchaskara churna with
Ksheerbala Taila Matra Basti with Rasna Guggulu |
Anulomana with Panchasakar Churana 5 grams for first two days followed by Matra Basti with Ksheerbala Taila for 8 days followed by Rasna Guggulu 1 gram (500mg each tablet) three times a day for 30days |
|
Inclusion Criteria
|
Age From |
16.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
1. Patients with Classical sign & symptoms of Gridhrasi and diagnosed cases of sciatica.
2. Sciatica due to lumber disc degenerative diseases.
3. Sciatica due to degenerative changes in the joints of lumbar Vertebrae.
|
|
ExclusionCriteria |
Details |
1. Patients with severe renal and cardiac diseases.
2. Pregnant women
3. malignancy
4. Infectious conditions of spine
5. Patient who have lost the control on bowel and bladder.
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
patients of either sex 16-70 yr old diagnosed with Gridhrasi (sciatica) will be selected for relief in sign and symptoms |
70 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
1 To assess the effect of Erandmooladi Yoga Basti & Rasna Guggulu in Gridhrasi (sciatica)
2 To assess the effect of Matra Basti with Ksheerbala Taila & Rasna Guggulu in Gridhrasi (sciatica)
3 To compare the efficacy between the Erandmooladi Yoga Basti and Matra Basti
|
70 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 |
Date of First Enrollment (India)
|
10/10/2017 |
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="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Not yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Present day life style
has created several health related problems; mainly musculo-skeletal disorders;
One among them is sciatica and low back pain. Low back pain affects the quality
of life particularly in most productive period of life. The incidence rate of this
disease is significant as more than three quarters of the world’s population
experience low back pain at some or other time during their life time. It is most common cause of sickness which results in absence
from work. The person who suffers from this disease is partially handicapped,
as the patient may not be able to walk, stand or sit comfortably.
Sciatica is very painful condition in which pain begins in lumber region
and radiate along the postero lateral aspect of the thigh and leg. Based on
sign and symptoms sciatica can be correlated with Gridhrasi in Ayurveda which is considered as Shool pradhan Vata vayadhi. The cardinal sign and symptoms of Gridhrasi
are Ruk(pain),Toda(pricking type of pain), Stambha
(stiffness) and Muhu spanda (twitching) in the Sphika, Kati,Uru, Janu,Jangha and Pada in order and Sakhthishepa nigraha
i.e. restricted lifting of the leg.
In modern medicine mainly treatment
is concerned about pain management or surgical correction of the pathology. In Ayurveda holistic treatment is
explained. Basti is said to be
superior treatment for Vata Vyadhi.
More over in Chikitsa sutra of Gridhrasi, Basti is advised further Erandmooladi Basti is specifically advised in the symptoms complex similar to Gridhrasi.
The
reason for selection of this disease is because of its prevalence in the
society and its effect on quality of life. In modern science if pain and
neurological defects do not subside on prolonged conservative treatment,
finally surgery is considered, which is not a right choice as it may leads to
several complications like permanent
damage to the spinal cord / Nerves , loss of working capabilities on one side
and on the other side it is an costly affairs. So there is need to find out safe,
cost effective, long lasting and non invasive treatment.
Basti is commonly advised for the treatment of Gridhrasi. The combination of Niruha and Anuvasana Basti is a
costly affair and require hospitalization and strict code of conduct, on the
other side Matra Basti is much safe,
cost effective and devoid of code of conduct. Hence the present study is
planned with following aims and objectives.
|