| CTRI Number |
CTRI/2019/05/019048 [Registered on: 10/05/2019] Trial Registered Prospectively |
| Last Modified On: |
21/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the effect of Adityapaka guggulu, Shunthyadi Kwatha and Kati Basti in the Management of Katigatavata Roga (Lumber Spondylosis) |
|
Scientific Title of Study
|
Clinical evaluation of Adityapaka guggulu, Shunthyadi Kwatha and Kati Basti in the Management of Katigatavata Roga (Lumber Spondylosis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajay Kumar Sahu |
| Designation |
Assistant Professor |
| Affiliation |
National Institute Of Ayurveda |
| Address |
PG Department of Kayachikitsa National Institute Of
Ayurveda Madhav Vilas Palace Amer Road Jaipur
RAJASTHAN
302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9950708106 |
| Fax |
|
| Email |
drajaysahu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Kumar Sahu |
| Designation |
Assistant Professor |
| Affiliation |
National Institute Of Ayurveda |
| Address |
PG Department of Kayachikitsa National Institute Of
Ayurveda Madhav Vilas Palace Amer Road Jaipur
RAJASTHAN
302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9950708106 |
| Fax |
|
| Email |
drajaysahu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lalita Verma |
| Designation |
PG Scholar |
| Affiliation |
National Institute Of Ayurveda |
| Address |
PG Department of Kayachikitsa National Institute Of
Ayurveda Madhav Vilas Palace Amer Road Jaipur
RAJASTHAN
302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9694817590 |
| Fax |
|
| Email |
nishaverma8496@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Madhav Vilas Palace Amer Road Jaipur Rajasthan |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Madhav Vilas Palace Amer Road Jaipur 302002 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Lalita Verma |
National Institute of Ayurveda Hospital Jaipur |
OPD No 1, 7, 18,25 Deprt. of Kayachikitsa , Madhav Vilas Palace Amer Road Jaipur, 302002
RAJASTHAN
Jaipur
RAJASTHAN |
9694817590
nishaverma8496@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE OF NATIONAL INSTITUTE OF AYURVEDA JAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M479||Spondylosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP A |
10 Patients will be treated by Adityapaka guggulu 2 tab. (each tab. of 500 mg) three times in a day with lukewarm water and Shunthyadi Kwatha 50 ml in morning (one time in a day) for 30 days. |
| Intervention |
GROUP B |
10 patients will be treated by Kati Basti with Ashwagandhadi Taila (Kalpita Yoga) for 45 minutes daily once a day in morning for 14 days. |
| Intervention |
GROUP C |
10 Patients will be treated by Adityapaka guggulu 2 tab. (each tab. of 500 mg) three times in a day with lukewarm water and Shunthyadi Kwatha 50 ml in morning (one time in a day) for 30 days, along with Kati Basti with Ashwagandhadi Taila(Kalpita Yoga) for 45 minutes. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients willing to signature the consent form for the clinical trial.
2.Patients having sign and symptoms of Katigatavata Roga (Lumber Spondylosis).
3.Patients with chronicity of Katigatavata Roga (Lumber Spondylosis) less than 10 years. |
|
| ExclusionCriteria |
| Details |
1.Patients with chronicity of Katigatavata Roga (Lumber Spondylosis) more than 10 years.
2.Patients suffering with k/c/o potts spine, tumors of spine, focal neuropathy and any septic or infectious disease of spine.
3.Pregnant and lactating mother.
4.Recent cervical, spinal, shoulder surgery or implanted instrumentation or previous surgery for lumber spondylotic myelopathy.
5.K/C/O Stenosis of spinal canal.
6.Patient suffering with Diabetes or Diabetic neuropathy, Gout, Rheumatoid Arthritis and fracture of hip bone, Septic Arthritis and Paralysis. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in their growing feeling of well being or any improvement in the following sign and symptoms of "Katigatavata Rogaâ€(Lumber Spondylosis) like Ruk (Pain), Pain with rest, Pain on movement, Stabdhata (Stiffness), Toda (Tingling Sensation), Anidra (Insomnia), Suptata (numbness), Mansa Balakshya. |
1 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in
1.Functional Assessment e.g. Lumber movement
2.Walking time e.g. Time taken to cover the distance of 30 meters
3.S.L.R. Test
4.Laboratory and Radiological investigation |
1 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 2 |
|
Date of First Enrollment (India)
|
03/06/2019 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Suspended |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Ayurveda is most ancient science of life. The aim of Ayurvedic system of medicine is not only to cure the disease but also to maintain the health of healthy person. It is very potent medical science which not only cures disease but also has the capacity to prevent its replace by breaking down the basic chain of reactions necessary for the pathology of disease through Shodhana and Shamnachikitsa . Acharya Charaka described the disease of Asthigatavata in Vatavyadhichikitsa and defined this as a disease with the symptoms of Ashthi bheda (breaking pain) Parvabheda, Sandhishoola (pain in joints), Mamsa balakshaya (muscle weakness), Aswapna (diminished sleep) and Santat ruk (continous pain). The term katigatavata Roga has a clear resemblance with Lumber spondylosis mentioned in modern text books of Orthopaedic. Spondylosis is a degenerative disorder which affects intervertebral discs and facet joint that may cause loss of normal spinal structure and function. Both refer to Single similar. Presentation Low back Pain that is increased with movement and associated with stiffness. Lumber spondylosis is more common between 30 to 60 yrs. of age. Pain may radiate into the buttocks or legs and aggravated by prolonged sitting or standing. Spondylosis can affect the lumber (low back) thoracic (mid back), cervical (neck) region of spine. This probably mean by ’Vata Prakopa’ in similar terms. In this era of globalization due to excessive use of vehicles and increased work load degenerative changes occur more in lumber spine of people so the incidence of Katigatavata Roga (Lumber spondylosis) is increasing. Since the management of Lumber spondylosis with modern medicine is temporary and many cases require surgical intervension which may produce serious problems and side effects. So Ayurvedic management seems to be more satisfactory because of their long lasting effects and multiple systemic regenerative actions without any harm. AIMS AND OBJECTIVES OF STUDY 1.Conceptual and clinical study on Katigatavata Roga (Lumber Spondylosis). 2.To evaluate the efficacy of Adityapaka guggulu and Shunthyadi Kwatha in the management of Katigatavata Roga (Lumber Spondylosis) 3.To evaluate the efficacy of Kati Basti in the management of Katigatavata Rog (Lumber Spondylosis). 4.To evaluate the combined efficacy of Adityapaka guggulu Sunthyadi Kwatha and Kati Basti in the management of Katigatavata Roga (Lumber Spondylosis). |