| CTRI Number |
CTRI/2017/02/007850 [Registered on: 14/02/2017] Trial Registered Retrospectively |
| Last Modified On: |
11/02/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
TO compare the effect of Kala Basti and Kati Basti along with Nirgundi ghan vati in Gridhrasi (Sciatica) |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY ON THE EFFICACY OF KALA BASTI AND KATI BASTI ALONG WITH NIRGUNDI GHAN VATI 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 Akanksha Sharma |
| Designation |
Pg scholar |
| Affiliation |
Govt Akhandanand Ayurvedic College |
| Address |
Upgraded department of Panchakarma
Govt Akhandanand Ayurvedic College Bhadra Ahmedabad
Ahmadabad
GUJARAT
380001
India |
| Phone |
9924895789 |
| Fax |
|
| Email |
sharma.akanksha1085@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sweety Ruparel |
| Designation |
Incharge Head of Department and Proffesor |
| Affiliation |
Govt Akhandanand Ayurvedic College |
| Address |
Upgraded Department of Panchakarma
Govt Akhandanand Ayurvedic College Bhadra Ahmedabad
Ahmadabad
GUJARAT
380001
India |
| Phone |
9429202048 |
| Fax |
|
| Email |
sweetyruparel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sweety Ruparel |
| Designation |
Incharge Head of Department and Proffesor |
| Affiliation |
Govt Akhandanand Ayurvedic College |
| Address |
Upgraded Department of Panchakarma
Govt Akhandanand Ayurvedic College Bhadra Ahmedabad
Ahmadabad
GUJARAT
380001
India |
| Phone |
9429202048 |
| Fax |
|
| Email |
sweetyruparel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Akhandanand Ayurvedic College and Hospital and Maniben Ayurved Hospital Ahmedabad |
|
|
Primary Sponsor
|
| Name |
Govt Akhandanand Ayurvedic College and Hospital and Maniben Ayurved Hospital |
| Address |
OPD and IPD of Panchkarma Department Govt Akhandanand Ayurvedic College and Hospital and Maniben Ayurved Hospital 380001 |
| 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 Akanksha Sharma |
Govt Akhandanand Ayurvedic College and Hospital and Maniben Ayurved Hospital |
OPD of Panchakarma room no 11 and IPD of Panchkarma Govt Akhandanand Ayurvedic College and Hospital 380001 OPD of Panchakarma room no 23 Post graduate section Maniben Ayurved Hospital Ahmedabad
Ahmadabad
GUJARAT |
09924895789
sharma.akanksha1085@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
GRIDHRASI(SCIATICA), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kala Basti along with Nirgundi ghan Vati |
Total 15 Basti will be administered to the patient in the course of Kala Basti followed by Shaman with Nirgundi ghan Vati for 4 weeks
Dose- Asthapan Basti-510ml (Madhu-60ml, Saindhav-10gm, Nirgundi TAila-80ml, Pootoyavaniadi Kalka- 40gm, Erandmoola Kwath-320ml
Anuvasan Basti-80ml with Nirgundi Taila
Basti pradan kala- Asthapan- Jirnanna Kala and Anuvasan- After meal noon time
Shaman- After completion of Kala Basti Nirgundi ghan Vati will be given in a dose of vati (250mg each) three times a day
Anupan- Ushanodak |
| Comparator Agent |
Kati Basti along with Nirgundi ghan Vati |
Total 15 Kati Basti will be administered followed by shaman with Nirgundi ghan Vati for 4 weeks
Kati Basti- An artificial pit will be made around lumbosacral area of back with the help of Masha dough covering L4 to S3 vertebre. The pit will be 2 inches in height and 4 inches in diameter. Nirgundi taila will be poured in it having a temperature range of 40 to 42 degree celcius. The temperature of the oil will be maintained through out the procedure.
Duration- 30 minutes for 15 days
Shaman- After completion of Kati Basti Nirgundi ghan Vati will be given in a dose of 4 vati(250mg each) three times a day.
Anupan- Ushanodak |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having classical signs and symptoms if Gridhrasi i.e Ruka, Toda, Stambha Spandan in Sphika Kati Uru Janu Jangha AND Pada.
2.Classical signs and symptoms of Sciatica.
3.Patients indicated for Basti karma according to Ayurvedic classics |
|
| ExclusionCriteria |
| Details |
1.CA Spine
2.Major traumatic injury
3.Tumors of cauda equina
4.Cases of surgical intervention
5.Chronic debilitating diseases like DM TB etc |
|
|
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 |
| Assessment will be done on the specially designed proforma or assessing sign and symptoms in scoring pattren. |
1.5 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment will be done on the specially designed proforma or assessing sign and symptoms in scoring pattren. |
1.5 months |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
27/06/2016 |
| 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) |
Open to Recruitment |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomised parallel group trial being conducted in Department of Panchakarma at Govt Akhandanad Ayurvedic Collegeand hospital Ahmedabad Gujarat, dealing with treatment of disease Gridhrisi(Sciatica). Acharya Charak has mentioned that it should be treated with drugs having Vatakaphahar, Vednasthapan, and Vrishya properties. The drugs of Kala Basti and Nirgundi ghan Vati have all properties. Therefore in present study Kala Basti and Nirgundi ghan Vati has been selected for clinical trial in group A. Kati Basti with Nirgundi Taila and Nirgundi ghan Vati has been selected for clinical trial in Group B. Methods- Kala BastiI-will be administered as per classical method of Basti. Asthapan Basti- Jirnanna kala, Anuvasan- after meal noon time for 15 days. Kati Basti- An artifical pit will be made around lumbosacral area of the back with the help of masha dough covering L4 to S3 vertebrae. The pit will be 2 inches in height and 4 inches in diameter. Nirgundi taila will be poured in it having a temperature range of 40 to 42 degree celcius. The temperature of the oil will be maintained throughout the procedure and the procedure for a duration of 30 minutes for 15 days. In both groups Nirgundi ghan Vati will be given after the completion of Kala Basti and Kati Basti with luke warm water for 4 weeks
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