| CTRI Number |
CTRI/2018/07/015072 [Registered on: 26/07/2018] Trial Registered Prospectively |
| Last Modified On: |
24/07/2018 |
| 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
|
Ayurvedic Management on Lumbar Spondylosis |
|
Scientific Title of Study
|
A Clinical Comparative Study on Effect of Erandamula Ghanavati, Panchatikta Kshira Basti with and without Kati Basti in Katigrah with special reference to Lumbar Spondylosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Darshana Bakaram Chaure |
| Designation |
MD Kayachikitsa (PG Scholar) |
| Affiliation |
Government Ayurved College Nagpur |
| Address |
Department of Kaychikitsa, Room no.1 (O.P.D.No.-1), Government
Ayurved College and Hospital, Sakkardara Chowk Nagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9168833371 |
| Fax |
07122749198 |
| Email |
darshanachaure39@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kabra R Prakash |
| Designation |
Professor |
| Affiliation |
Government Ayurved College and Hospital Nagpur |
| Address |
Department of Kayachikitsa,Government Ayurved College and
Hospital Nagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9225226567 |
| Fax |
07122749198 |
| Email |
kabraprakash2711@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kabra R Prakash |
| Designation |
Professor |
| Affiliation |
Govt.Ayurved College,Nagpur |
| Address |
Department of Kayachikitsa,Government Ayurved College and
Hospital Nagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9225226567 |
| Fax |
07122749198 |
| Email |
kabraprakash2711@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self (Darshana Bakaram chaure) Department of Kaychikitsa Government Ayurved College and Hospital Nagpur
|
|
|
Primary Sponsor
|
| Name |
Government Ayurved College Nagpur |
| Address |
Government Ayurved College and Hospital Sakkardara Nagpur |
| Type of Sponsor |
Other [Government Ayurved College Nagpur] |
|
|
Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Darshana Bakaram Chaure |
Government Ayurved College and hospital Nagpur |
Department of
Kaychikitsa
Government Ayurved
College and hospital
Nagpur
MAHARASHTRA |
9168833371
07122749198
darshanachaure39@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee,Government Ayurved College,Nagpur |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
with controlled systemic disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral administration of Erandamula Ghanavati in the dose of 500 mg tablet 2 BD per day for a period of 30 days, Panchatikta Kshirabasti 240ml. Panchatikta Kshira Basti per anus, once daily in the morning at about 10 o,clock for 15 days duration and local application of Katibasti on lumbar vertebre region for half an hour before Pancnatikta Kshira Basti. Use of Katibasti will be done for 15 days only. Fater comletion of Panchatikta Kshira Basti per anus and local application of Kati Basti. Erandamula Ghanavati will be prescribed continously for further 15 days.(Erandamula Ghanavti will be given for 30 days. |
These patients will be classified in to two groups of management.These group will be termed as Group A and Group B. These patients will be categorized in to Group A and Group B by lottery method with patients in each group. Erandamula Ghanavati, Panchatikta Kshirabasti and Katibasti will be administered to the patients of Group A.
|
| Comparator Agent |
Oral administration of Erandamula Ghanavati in the dose of 500 mg tablet 2 BD per day for a period of 30 days, Panchatikta Kshirabasti 240ml. Panchatikta Kshira Basti per anus, once daily in the morning at about 10 o,clock for 15 days duration.Fater comletion of Panchatikta Kshira Basti per anus.
|
Erandamula Ghanavati 500mg BD for 30 days, Panchatikata Kshirabasti will be administered for 15 days in Group B.
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.The Roland-Morris low back pain and disability questionnaire; if RDQ score>5.
2. Radiological changes, degenerative changes in Lumbar spine.
3. Patients having sign and symptoms of Katigrah according to classics.
4. Patient willing and able to participate in the study.
5. Chronic low back pain more than three month
|
|
| ExclusionCriteria |
| Details |
1) History of any fracture of vertebral joint/ surgical/ diagnostic intervention with reference to affected joints will be excluded. 2) Gross disability in performing daily normal routine i.e. bedridden patient or confined to a wheelchair will be excluded.
3) Patient with co morbidities such as gouty arthritis, rheumatoid arthritis or psoriatic arthritis, tubercular arthritis.
4) Patient with any deformity of hip or back altering the gait and posture of the patient, ankylosing spondylitis, spinal inflammatory disorders.
5) Patient with uncontrolled hypertension (?160/100mm of Hg) and uncontrolled diabetes (Blood sugar level fasting >125mg/dl and post lunch >200mg/dl) will be ruled out.
6) Patient with evidence of malignancy.
7) Patient on prolonged (?6weeks) medication with corticosteroids, non-steroidal anti-inflammatory drug, antidepressants, anti-cholinergic etc. or any drugs that may influence on the outcome of the study.
8) Patient who have a past history of any other systemic disorders will be excluded in doubtful cases.
9) Pregnant / lactating women.
10) Patients who had participated in any other clinical trial since last six months.
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Evaluate the effect of Erandamula Ghanavati, Panchatikta Kshira Basti along with Kati Basti particularly on the Roland and Morris index, low back pain and disability questionnaire and clinical features of Katigrah with special reference to Lumbar Spondylosis. 2. To compare the effect of Erandamula Ghanavati, Panchatikta Kshira Basti along with Kati Basti with Erandamula Ghanavati annd Panchatikta Kshira Basti. |
1)Before start of treatment i.e.day zero 2)Duration of Treatment: Erandamula Ghanavati(30 days, Panchatikta Kshira Basti(15 days) Kati Basti(15 days) Effect of all above will be assessed on 16 th day. This will be second assessment. 3)Effect of all above will be assessed on 31rst day. this will be third assessment and will be termed as after treatment.
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|
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Secondary Outcome
|
| Outcome |
TimePoints |
1. To study literature of Katigrah from texts.
2. To study lumbar spondylosis from modern point of view.
3.Standardization of Panchatikta Bharad used Basti.
|
18 months |
|
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Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
03/08/2018 |
| 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 |
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Publication Details
|
none yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
Lumbar spondylosis is the most common progressive disorder in the ageing lumbar spine. It results from the process of degeneration of the vertebral discs and facet joints of lumbar spine. In Ayurveda its feature resembles with that Katigrah. In Ayurvedic texts its management is done on the basis of Samanya Chikitsa of Vatavyadhi which contain Snehana, Svedana, Basti and oral drugs. In this study will be evaluate the efficacy of Erandamula Ghanavati orally along with Panchatikta Kshira Basti and Kati Basti. Amidst this background, the eyes tried are looking towards Ayurveda with great hope of getting relieved from the deadly agonizing pain. Low back pain can be correlated with Katishula in Ayurved, meaning Shula at the particular site Kati, Kasheruka and Trik Asthi. The particular symptom Katishula may be found in different disease having varied etiology. Particularly while relating lumbar spondylosis, the main significant cause of Katishula is Asthi Dhatu Kshaya. Vata Dosha as described by Sushruta is responsible for Ruja or Shula (Su.Su.17/12)[11]. Vata is not only related with Katishula for its dominant role played in the pathology of Shula, but also Vata has said to have inversely proportionate relationship with Asthi Dhatu as Ashrya-Ashryi relation (A.H.Su.11/27-28)[12].Asthi Dhatu Kshaya result in Vata Prakopa and vice versa. Bony degenerative changes may relate Asthi Dhatu Kshaya and thus cause of vitiation of Vayu. Aim is to evaluate the efficacy of Erandmula Ghanavati along with Panchatikta Kshira Basti and Kati Basti.
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