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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)”  
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)”  
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 â€˜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.



 

 
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