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CTRI Number  CTRI/2025/03/083350 [Registered on: 25/03/2025] Trial Registered Prospectively
Last Modified On: 19/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   TO COMPARE THE EFFICACY OF ASHWAGANDHADYA GHRITA PANA AND NASYA ALONG WITH RASNAPANCHAK KWATHA AND GUGGULU VATI IN THE MANAGEMENT OF CERVICAL SPONDYLOSIS  
Scientific Title of Study   A RANDOMISED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF ASHWAGANDHADYA GHRITA PANA AND NASYA ALONG WITH RASNAPANCHAK KWATHA AND GUGGULU VATI IN MANAGEMENT OF CERVICAL SPONDYLOSIS (GREEVA SANDHIGATAVATA) 
Trial Acronym  CS  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  RACHNA SHARMA 
Designation  PG SCHOLAR 
Affiliation  NATIONAL INSTITUTE OF AYURVEDA, JAIPUR 
Address  NATIONAL INSTITUTE OF AYURVEDA, MADHAV VILAS, AMER ROAD, JAIPUR, RAJASTHAN, INDIA
NATIONAL INSTITUTE OF AYURVEDA, MADHAV VILAS, AMER ROAD, JAIPUR, RAJASTHAN, INDIA
Jaipur
RAJASTHAN
302002
India 
Phone  9461523058  
Fax    
Email  rachna1295@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR RASHMI MUTHA  
Designation  ASSISTANT PROFESSOR 
Affiliation  NATIONAL INSTITUTE OF AYURVEDA, JAIPUR 
Address  DEPARTMENT OF KAYACHIKITSA, NATIONAL INSTITUTE OF AYURVEDA, DEEMED TO BE UNIVERSITY, NEAR JORAWAR SINGH GATE, AMER ROAD, JAIPUR, RAJASTHAN
DEPARTMENT OF KAYACHIKITSA, NATIONAL INSTITUTE OF AYURVEDA, DEEMED TO BE UNIVERSITY, NEAR JORAWAR SINGH GATE, AMER ROAD, JAIPUR, RAJASTHAN
Jaipur
RAJASTHAN
302002
India 
Phone  7976512056  
Fax    
Email  rashmimutha21@yahoo.com  
 
Details of Contact Person
Public Query  
Name  DR RASHMI MUTHA  
Designation  ASSISTANT PROFESSOR 
Affiliation  NATIONAL INSTITUTE OF AYURVEDA, JAIPUR 
Address  DEPARTMENT OF KAYACHIKITSA, NATIONAL INSTITUTE OF AYURVEDA, DEEMED TO BE UNIVERSITY, NEAR JORAWAR SINGH GATE, AMER ROAD, JAIPUR, RAJASTHAN
DEPARTMENT OF KAYACHIKITSA, NATIONAL INSTITUTE OF AYURVEDA, DEEMED TO BE UNIVERSITY, NEAR JORAWAR SINGH GATE, AMER ROAD, JAIPUR, RAJASTHAN
Jaipur
RAJASTHAN
302002
India 
Phone  7976512056  
Fax    
Email  rashmimutha21@yahoo.com  
 
Source of Monetary or Material Support  
NATIONAL INSTITUTE OF AYURVEDA, DEEMED TO BE UNIVERSITY, JAIPUR, RAJASTHAN 
 
Primary Sponsor  
Name  NATIONAL INSTITUTE OF AYURVEDA DEEMED TO BE UNIVERSITY DEEMED TO BE UNIVESRITY JAIPUR 
Address  NEAR JORAWAR SINGH GATE, AMER ROAD, JAIPUR 302002, RAJASTHAN 
Type of Sponsor  Other [CENTRAL GOVERNMENT FUNDED AYURVEDA RESEARCH INSTITUTION AND HOSPITAL] 
 
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 
RACHNA SHARMA  HOSPITAL OF NATIONAL INSTITUTE OF AYURVEDA, DEEMED TO BE UNIVERSITY, JAIPUR, RAJASTHAN  OPD ROOM NO. 1, 18, AND 25, DEPARTMENT OF KAYACIKITSA, AYURVEDA SATELLITE HOSPITAL OPD, JAWAHAR NAGAR, JAIPUR
Jaipur
RAJASTHAN 		 9461523058

rachna1295@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, NATIONAL INSTITUTE OF AYURVEDA, DEEMED TO BE UNIVERSITY (DE-NOVO), JORAWAR SINGH GATE, AMER ROAD, JAIPUR, 302002  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M478||Other spondylosis. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: ASHWAGANDHADYA GHRITA , Reference: CHAKRADUTTA VATAVYADHI CHIKITSA, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: USHNA JALA), Additional Information: -
(2) Medicine Name: RASNAPANCHAK KWATHA , Reference: CHAKRADUTTA, AMAVATA CHIKITSA, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: -
(3) Medicine Name: GUGGULU VATI, Reference: SUSHRUTA SAMHITA VATAVYADHI CHIKITSA, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: KWATHA), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: RASNAPANCHAK KWATHA , Reference: CHAKRADUTTA AMAVATA , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -), Additional Information: -
(2) Medicine Name: GUGGULU VATI , Reference: SUSHRUTA VATAVYADHI CHIKITSA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: KWATHA), Additional Information: -
3Intervention ArmDrugClassical(1) Medicine Name: ASHWAGANDHADYA GHRITA, Reference: CHAKRADUTTA VATAVYADHI CHIKITSA, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 1(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients of either gender having age between 30-70 years
2. Patients with clinical signs and symptoms of Greeva sandhigata vata (Cervical Spondylosis)
3. Patients having a radiological finding of Cervical Spondylosis
4. Patients fit for Nasya karma and Snehapana
 
 
ExclusionCriteria 
Details  1. Recent cervical, spinal, or shoulder trauma or surgery or any implantation in these sites
2. History of Cervical Spondylotic Myelopathy, Cervical Rib, severe Cervical Radiculopathy
3. Patients having systemic illness such as Ankylosing spondylitis, diffuse idiopathic skeletal hyperostosis, inflammatory arthritis
4. Patients having suspected TB or HIV infection, vascular insufficiency or malignancy
5. Pregnant or lactating women
6. Patients having known allergy to any of the trial drug
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of the study will be the change in Neck Disability Index Score   At baseline and after four weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcomes will include changes in scoring of subjective parameters assessing pain, neck stiffness and active neck movements (From baseline to the end of the treatment period)  After four weeks 
 
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   Phase 3 
Date of First Enrollment (India)   01/07/2025 
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="28" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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   The study titled "A Randomized Comparative Clinical Study to Evaluate the Efficacy of Ashwagandhadya Ghrita Pana and Nasya along with Rasnapanchak Kwatha and Guggulu Vati in Cervical Spondylosis (Greeva Sandhigatavata)" is a postgraduate research project in Ayurveda.

Background

Cervical Spondylosis is a degenerative condition affecting the cervical spine, leading to neck pain, stiffness, and neurological complications. The study correlates this condition with Greeva Sandhigata Vata in Ayurveda and aims to explore the effectiveness of Ayurvedic treatments for pain relief and functional improvement.

                 I.               Null Hypothesis [Ho]- There is no difference between the efficacy of Ashwagandhadya ghritapana and nasya along with Rasnapanchak kwatha and Guggulu Vati in Cervical Spondylosis

              II.               Alternative Hypothesis [HA]- There is difference between the efficacy of Ashwagandhadya ghritapana and nasya along with Rasnapanchak kwatha and Guggulu Vati in Cervical Spondylosis

Study Design

  • Type: Randomized, Comparative Clinical Trial
  • Participants: 40 patients (30–70 years) diagnosed with Cervical Spondylosis
  • Groups:
    • Group A: Ashwagandhadya Ghrita Pana, Guggulu Vati, and Rasnapanchak Kwatha
    • Group B: Ashwagandhadya Ghrita Nasya, Guggulu Vati, and Rasnapanchak Kwatha
  • Duration: 28 days with follow-up after 1 month

Treatment & Methodology

  • Ashwagandhadya Ghrita is used for its Vata-balancing and Brimhana properties.
  • Guggulu Vati supports joint health and reduces inflammation.
  • Rasnapanchak Kwatha relieves pain, strengthens muscles, and improves digestion.
  • Efficacy is measured using the Neck Disability Index (NDI), pain scales, and radiological findings.

Outcome & Significance

The study aims to provide scientific evidence on Ayurvedic treatments as an alternative to conventional therapies, reducing dependency on NSAIDs and steroids while improving patients’ quality of life.

 
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