CTRI Number |
CTRI/2020/10/028631 [Registered on: 26/10/2020] Trial Registered Prospectively |
Last Modified On: |
23/10/2020 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda Other (Specify) [Interventional Therapy] |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
“Role and effect of ayurvedic intervention in the management of Sandhigata Vata of Kati (Lumbar spondylosis)â€
|
Scientific Title of Study
|
“A randomized controlled clinical trial to evaluate the efficacy of Ayurvedic intervention in the management of Sandhigatavata of Kati (Lumbar spondylosis)â€
|
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Niharika Shakya |
Designation |
Ph.D Scholar |
Affiliation |
Faculty of Ayurveda IMS Banaras Hindu University Varanasi |
Address |
Department of Kayachikitsa Faculty of Ayurveda IMS BHU Varanasi
Varanasi UTTAR PRADESH 221005 India |
Phone |
9024025873 |
Fax |
|
Email |
nshakya07089@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Jai Prakash Singh |
Designation |
Associate Professor |
Affiliation |
Faculty of Ayurveda IMS Banaras Hindu University Varanasi |
Address |
Panchakarma Unit Department of Kayachikitsa Faculty of Ayurveda IMS BHU Varanasi
Varanasi UTTAR PRADESH 221005 India |
Phone |
9415814351 |
Fax |
|
Email |
drjp98@yahoo.co.in |
|
Details of Contact Person Public Query
|
Name |
Niharika Shakya |
Designation |
Ph.D Scholar |
Affiliation |
Faculty of Ayurveda IMS Banaras Hindu University Varanasi |
Address |
Department of Kayachikitsa Faculty of Ayurveda IMS BHU Varanasi
Varanasi UTTAR PRADESH 221005 India |
Phone |
9024025873 |
Fax |
|
Email |
nshakya07089@gmail.com |
|
Source of Monetary or Material Support
|
Department of Kayachikitsa, Faculty of Ayurveda, IMS, Banaras Hindu University, Varanasi Uttar Pradesh |
|
Primary Sponsor
|
Name |
Central Council for Reasearch in Ayurvedic Sciences |
Address |
61-65, opp. D Block, Janakpuri Institutional Area, Janakpuri, New Delhi, Delhi 110058 |
Type of Sponsor |
Government funding agency |
|
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 Niharika Shakya |
Banaras Hindu University |
Department of Kayachikitsa IMS Banaras Hindu University Varanasi UTTAR PRADESH |
9024025873
nshakya07089@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICS COMMITTEE IMS BHU VARANASI |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M478||Other spondylosis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Methylcobalamine, Pregabaline, Diclofenac,Methyl prednisolone |
Group-A 50 Patients will be administered controlled group Methylcobalamine (750mcg) pregabaline (75mg) – 1 Once daily for 3 months , Diclofenac 100mg – 1 Once daily for 15 days then SOS basis, Methyl prednisolone – 8mg for first 5days then 4 mg next 5 days then 4 mg alternate days orally for 15 days . |
Intervention |
Rasnadashmooladi Kwatha Abhyanga, Swedana, Panchprasrutika Basti |
Group B 50 patients will be performed Bahya Snehana, Swedana and Basti Karma for 15 days/month along with the trial drug “Rasnadashmooladi Kwatha†40ml twice a day before meal orally for 3 month. |
|
Inclusion Criteria
|
Age From |
30.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1.Patients willing for trial and give consent.
2.Patients of age group 30 to 60 years of either sex.
3.Patients having signs and symptoms of Sandhigatavata of Kati (lumbar spondylosis) as mentioned in Ayurvedic and Modern texts.
|
|
ExclusionCriteria |
Details |
1.Patients not willing for trial.
2.Age below 30 and above 60 years of either sex.
3.Patients having serious accidental injuries involving structural deformity.
4.Patients with Potts spine, spinal and paravertebral tumors.
5.Patients with fractures, kyphosis, scoliosis, osteoporosis
6.Patients with rectal or vaginal prolapsed, metastatic and uterine conditions.
7.Pregnant and lactating women.
8.Patients suffering from serious systemic disorders like renal diseases, heart diseases, malignant hypertention, diabetes mellitus.
|
|
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 |
Patients of both sexes between age group 30-60
of Sandhigata Vata of Kati Pradesh will be selected for relieving
signs and symptoms |
3 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
Assess the comparative efficacy between
Ayurvedic intervention and Control group after 3
months in case of Sandhigatavata of Kati. |
3 months |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
30/10/2020 |
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="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Sandhigatavata is mentioned under Vata Vyadhi.
Acharya Charaka has mentioned that Nidan Sewana aggravates Vata and
this Vitiated Vata gets accumulated in Rikta Srotasa to
gives rise various generalized and localized diseases. In case, Vata is
vitiated in Kati Pradesh that leads to Katisandhigata
Vata. The symptomatology of Sandhigata Vata are Hanti
Sandhigataha (loss of function), Shoola (Pain), Aatopah (
Swelling), Vatapoorna Driti Sparshah (Feelings of air filled
in joints), Shotha (Inflammatory conditions), Prasaarana
Aakunachana Sah Vedanaa (Pian on flexion & extention). In
contemporary medical science, the similar condition of Lumbar Spine is
explained as Lumbar Spondylosis. Aims and
Objectives: 1. To assess the efficacy of
Ayurvedic intervention in the management of Sandhigatavata of Kati 2. To compare the effect of
Ayurvedic intervention with the control group in the management of Sandhigatavata of Kati 3. To study the
pathophysiology of Sandhigatavata of Kati ADMINISTRATION OF DRUG: 100
clinically diagnosed and registered patients of ‘Sandhigatavata of
Kati’ (Lumbar Spondylosis) will be divided randomly
into two groups. 50 patients will be included in each group. Group
A: Patients will be administered controlled group Methylcobalamine
(750mcg) pregabaline (75mg) – 1 Once daily for 3 months , Diclofenac 100mg – 1
Once daily for 15 days then SOS basis, Methyl prednisolone – 8mg for first
5days then 4 mg next 5 days then 4 mg alternate days orally for 15 days. Group
B: BahyaSnehana, Swedana and Basti Karma for
15 days/month along with the trial drug “Rasnadashmooladi
Kwatha†40ml twice a day before meal orally for 3 month.
Inclusion criteria- 1. Patients willing for trial and give
consent. 2. Patients of age group 30 to 60 years of
either sex. 3. Patients having signs and symptoms
of Sandhigatavata of Kati (lumbar spondylosis) as mentioned
in Ayurvedic and Modern texts. Exclusion criteria 1. Patients not willing for trial. 2. Age below 30 and above 60 years of
either sex. 3. Patients having serious accidental
injuries involving structural deformity. 4. Patients with Potts spine, spinal and
paravertebral tumors. 5. Patients with fractures, kyphosis,
scoliosis, osteoporosis 6. Patients with rectal or vaginal
prolapsed, metastatic and uterine conditions. 7. Pregnant and lactating women. 8. Patients suffering from serious
systemic disorders like renal diseases, heart diseases, malignant hypertention,
diabetes mellitus.
|