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CTRI Number  CTRI/2024/07/071177 [Registered on: 23/07/2024] Trial Registered Prospectively
Last Modified On: 12/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Ayurvedic Management Of the Combined Efficacy Of RUKSHANA AND SNEHANA THERAPIES IN MANYASTAMBHA W.S.R CERVICAL SPONDYLOSIS. 
Scientific Title of Study   A CLINICAL STUDY TO EVALUATE THE COMBINED EFFICACY OF RUKSHANA AND SNEHANA THERAPIES IN MANYASTAMBHA W.S.R CERVICAL SPONDYLOSIS. 
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 Murtuza  
Designation  MD SCHOLAR 
Affiliation  DR BRKR GOVT AYURVEDIC COLLEGE ,ERRAGADA HYDERABAD 
Address  ROOM NO 5 DEPARTMENT OF PANCHAKARMA DR BRKR GOVT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL ERRAGADA HYDERABAD

Hyderabad
TELANGANA
500038
India 
Phone  6303951057  
Fax    
Email  murtuza0738@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Praveen Kumar Madikonda  
Designation  Professor  
Affiliation  Dr.Brkr Govt Ayurvedic Medical College and Hospital  
Address  ROOM NO 5 DEPARTMENT OF PANCHAKARMA DR BRKR GOVT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL ERRAGADA HYDERABAD

Hyderabad
TELANGANA
500038
India 
Phone  9849271601  
Fax    
Email  pkmadikonda@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Praveen Kumar Madikonda  
Designation  Professor  
Affiliation  Dr.Brkr Govt Ayurvedic Medical College and Hospital  
Address  ROOM NO 5 DEPARTMENT OF PANCHAKARMA DR BRKR GOVT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL ERRAGADA HYDERABAD

Hyderabad
TELANGANA
500038
India 
Phone  9849271601  
Fax    
Email  pkmadikonda@gmail.com  
 
Source of Monetary or Material Support  
DR.BRKR GOVT AYURVEDA HOSPITAL SR NAGAR 500038 
 
Primary Sponsor  
Name  DR BRKR GOVT AYURVEDIC COLLEGE ERRAGADA HYDERABAD 
Address  DR BRKR GOVT AYURVEDIC COLLEGE AND HOSPITAL ERRAGADDA 
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 Murtuza   DR.BRKR GOVT AYURVEDIC COLLEGE AND HOSPITAL  ROOM NO 5 DEPT OF PANCHAKARMA DR.BRKR GOVT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL
Hyderabad
TELANGANA 		 6303951057

murtuza0738@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE of DR BRKR GOVT AYURVEDIC MEDICAL COLLEGE HYDERABAD  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M479||Spondylosis, unspecified. Ayurveda Condition: MANYASTAMBAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-dIpana , दीपन pAcana पाचन (Procedure Reference: Sushruta samhita , Procedure details: dIpana pAcana with chitrakadi vati and hinguvastaka churna for 5 days )
2Intervention ArmProcedure-anuvAsana-bastiH, अनुवासन-बस्तिः (Procedure Reference: bhaishajya ratnavali ४३/१११-११४, Procedure details: Anuvasana vasti for 7 days with brhat saindhavadi tail )
3Intervention ArmProcedure-grIvAbastiH, ग्रीवाबस्तिः (Procedure Reference: -SHARANGDHARA SAMHITA MADHYAMA KHANDA] ASHTANGA HRUDYAM CHIKISTA 29/66-68, Procedure details: Greeva vasti with Prasarini tail and sahacaradi tail for 7 days )
4Intervention ArmProcedure-nADIsvedaH, नाडीस्वेदः (Procedure Reference: Charak samhita , Procedure details: Nadi sweda for 7days)
5Intervention ArmProcedure-tailadhArA, तैलधारा (Procedure Reference: SHARANGDHARA SAMHITA MADHYAMA KHANDA,ASHTANGA HRUDYAM CHIKISTA 29/66-68, Procedure details: Greeva tailadhara for 7 days with Prasarini tail and sahacaradi tail.)
6Intervention ArmProcedure-recananasyam, रेचननस्यम् (Procedure Reference: Sharangadhara samhitha Madhyama khandha , Procedure details: Rechana Nasya with prasarini tail for 14 days )
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients having symptoms of ruk and stambha.
Age group between 20 to 70yr of both gender
Patient eligible for sweda and basti karma Nasya karma. 
 
ExclusionCriteria 
Details  Patient not eligible for swedana karma.
Patient not eligible for Basti karma, nasya karma. Patient with post cervical vertebral fractures, congenital deformities like congenital torticollis, cervical rib.
Patient with HIV, Malignancy, hepatitis, tuberculosis of spine, injuries to
cervical region.
Patient with uncontrolled DM (HbA1C – more than 9 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reducing the ama properties in body, reducing Pain during movements of neck  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Neck stiffness, Heaviness, full flexion, extension,rotation of neck   18 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   N/A 
Date of First Enrollment (India)   30/07/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 23-12-2024 and end date provided 23-09-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  

This is a randomized clinical trail to evaluate the combined efficacy of rukshana and snehana therapies in manyastambha wsr to cervical spondylosis

  Patients who will be clinically diagnosed  and confirmed cases of cervical spondylosis enlisted in inclusion criteria will be in single group of total  30 patients. They will be given Deepana ,Pachana ,Valuka sweda ,Anuvasana Vasti , Greeva vasti , Greeva Dhara,Nasya for  40 days .
Follow will be done for 40 days  and review for every two weeks.

 
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