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CTRI Number  CTRI/2024/10/075047 [Registered on: 10/10/2024] Trial Registered Prospectively
Last Modified On: 07/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare effect sahachara taila nasya and matra basti in vishwachi(cervical radiculopathy) 
Scientific Title of Study   Comparative Clinical Evaluation of Sahachara Taila Nasya and Matra Basti in Vishwachi(Cervical Radiculopathy) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Krishna Kumar Sharma 
Designation  Professor 
Affiliation  Rishikul Campus UAU, Haridwar 
Address  Department of Panchkarma, Rishikul Campus, Uttarakhand Ayurved University, Haridwar,Uttarakhand, India, Pin- 249401

Hardwar
UTTARANCHAL
249401
India 
Phone  9758264264  
Fax    
Email  kripayanam@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Krishna Kumar Sharma 
Designation  Professor 
Affiliation  Rishikul Campus UAU, Haridwar 
Address  Department of Panchkarma, Rishikul Campus, Uttarakhand Ayurved University, Haridwar,Uttarakhand, India, Pin- 249401

Hardwar
UTTARANCHAL
249401
India 
Phone  9758264264  
Fax    
Email  kripayanam@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Akhilesh Rawat 
Designation  P G Scholar 
Affiliation  Rishikul Campus UAU, Haridwar 
Address  Department of Panchkarma, Rishikul Campus, Uttarakhand Ayurved University, Haridwar,Uttarakhand, India, Pin- 249401

Hardwar
UTTARANCHAL
249401
India 
Phone  7895207198  
Fax    
Email  akhileshrawat0365@gmail.com  
 
Source of Monetary or Material Support  
Rishikul Campus, Uttarakhand Ayurved University, Haridwar, Pin-249401 
 
Primary Sponsor  
Name  Rishikul Campus, Uttarakhand Ayurved University, Haridwar 
Address  Rishikul Campus, Uttarakhand Ayurved University, Haridwar, uttarakhand, India, Pin-249401 
Type of Sponsor  Government medical college 
 
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 Akhilesh Rawat  Rishikul Campus, Uttarakhand Ayurved University, Haridwar  IPD and OPD no. 20, Rishikul Campus, Uttarakhand Ayurved University, Haridwar, Uttarakhand, India, Pin-249401
Hardwar
UTTARANCHAL 		 7895207198

akhileshrawat0365@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Uttarakhand Ayurved University, Rishikul Campus, Haridwar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M541||Radiculopathy. Ayurveda Condition: VISVACI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-nAvanam, नावनम् (Procedure Reference: sushruta samhita chikitsa sthana 40/25, Procedure details: Instil 8 Bindu of Sukhoshna Sahachara Taila into each nostril with the help of a dropper or cotton. The sole, shoulder, neck, ear & palm are gently massaged after the administration of the drug. After that the patient will be allowed to take rest in the supine position for 100 Matra Kala. The nasal secretion reaching the throat will be advised to spit out. then Kawala with Koshna Jala will be given. )
(1) Medicine Name: Sahachara Taila, Reference: Charak Samhita Chikitsa Sthana 28/144-145, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 30 Days
2Comparator ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: Charak Samhita Siddhi Sthan 3/17-19, Procedure details: The Matra Basti of Sahachara Taila will be administered with deep inspiration Then Uttanshayana with Tadan Karma at Prishtha, Sphika, Nitamba will be given.)
(1) Medicine Name: Sahachara Taila, Reference: Charak Samhita Chikitsa Sthana 28/144-145, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 30 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Patients irrespective of gender between the age group of 20 to 50 yrs.
2. Patient diagnosed with cervical radiculopathy according to assessment criteria (neck disability index).
3. Patients fit for Nasya Karma and Matra Basti. 
 
ExclusionCriteria 
Details  1. Severe hypertension and uncontrolled diabetes mellitus.
2. Known case of acute or chronic infection of the spine.
3. Paralyzed and traumatic causes like injury, accidents etc.
4. Known case of malignancy.
5. Any other form of arthritis like rheumatoid arthritis etc.
6. Pregnant and lactating women. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
No improvement: 0-25%
Mild improvement: 26-50%
Moderate improvement: 51-75%
Marked improvement: 76-99%
Complete remission: 100% 		 1st day, 11th day, 21st day, 31st day
 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of sign and symptoms  after one month of completion of therapy 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   N/A 
Date of First Enrollment (India)   18/10/2024 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Cervical radiculopathy arises from degenerative changes in the cervical spine. It commonly emerges during the fourth and fifth decades of life. Lifestyle factors, such as prolonged screen use, sedentary habits, and occupational strain, significantly contribute to its widespread occurrence. This ailment disrupts daily life, causing neck pain, radiating discomfort, and sensory disturbances. The contemporary surge in cervical radiculopathy highlights the impact of evolving lifestyles on musculoskeletal health, underscoring the need for proactive preventive measures. The Sushruta Samhita Nidana Sthana classifies Vishwachi under Vata Vikara, affecting the neck and upper extremities with symptoms akin to cervical radiculopathy. Both conditions share manifestations of Ruka, Stambha, Toda, Karmakshaya, and Chestapaharan of Bahu with Vata being the predominant Dosha responsible for Shoola. Due to the Snighdha Guna and Ushna Veerya of Sahachara Taila, It has Vata-Kapha Shamaka, Vednasthapana and Shothahara properties. In this study, we are comparing the effect of Sahachara Tail Matra Basti and Sahachara Tail Nasya in patients with classical symptoms of Vishwachi and fulfilling the diagnostic criteria of cervical radiculopathy.  
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