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CTRI Number  CTRI/2025/03/083015 [Registered on: 21/03/2025] Trial Registered Prospectively
Last Modified On: 20/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical study on Vishatindukadi vati and Asvagandhadya Taila in the management of Low back Pain 
Scientific Title of Study   Pharmaceutico – Analytical study of Vishatindukadi vati and Asvagandhadya Taila and it’s compartive clinical study in the management of Gridhrasi vis-à-vis Sciatica.  
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 Matteddula Upendra Reddy 
Designation  Post Graduate Scholar 
Affiliation  Dr.NRS Govt Ayurvedic College , Vijayawada 
Address  Department of Rasa shastra and Bhaishajya Kalpana Dr N R S Government Ayurvedic College M.G Road, Vijayawada, Andhra Pradesh.

Krishna
ANDHRA PRADESH
520002
India 
Phone  6281646227  
Fax    
Email  upendrareddym1996@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.K.SREEHARI  
Designation  Professor of Rasa shastra and Bhaishajya Kalpana 
Affiliation  Dr.NRS Govt Ayurvedic College , Vijayawada 
Address  Department of Rasa shastra and Bhaishajya Kalpana Dr N R S Government Ayurvedic College M.G Road, Vijayawada, Andhra Pradesh.

Krishna
ANDHRA PRADESH
520002
India 
Phone  9491925109  
Fax    
Email  dr.skovi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Matteddula Upendra Reddy 
Designation  Post Graduate Scholar 
Affiliation  Dr.NRS Govt Ayurvedic College , Vijayawada 
Address  Department of Rasa shastra and Bhaishajya Kalpana Dr N R S Government Ayurvedic College M.G Road, Vijayawada, Andhra Pradesh.

Krishna
ANDHRA PRADESH
520002
India 
Phone  6281646227  
Fax    
Email  upendrareddym1996@gmail.com  
 
Source of Monetary or Material Support  
Dr. Achanta Lakshmipathi Government Ayurvedic Hospital D. no. 23, 37-112, Near vijaykrishna super bazar, MG Road, Vijaywada, Andhra Pradesh, India Pin code: 520002 
 
Primary Sponsor  
Name  Dr Matteddula Upendra Reddy 
Address  Department of Rasa shastra and Bhaishajya Kalpana Dr N R S Government Ayurvedic College M.G Road, Vijayawada, Andhra Pradesh. 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
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 Matteddula Upendra Reddy  Dr Achanta Lakshmipathi Government Ayurvedic Hospital   OPD/Room no 10, Near Vijayakrishna super bazar, M.G Road, Vijayawada, Andhra Pradesh, 520002.
Krishna
ANDHRA PRADESH 		 6281646227

upendrareddym1996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M543||Sciatica. Ayurveda Condition: GRUDHRASI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Vishatindukadi Vati, Reference: Rasa Tantra saara va sidha prayoga sangraha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 125(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Water), Additional Information:
2Intervention ArmDrugClassical(1) Medicine Name: Asvagandhadhya Taila, Reference: Vangasena Samhita, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 2 Weeks, anupAna/sahapAna: No, Additional Information:
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Subjects of either gender between 20 to 60 years of age.
2.Subjects with classical features of Grdhrasi explained in classical texts.
3.Subjects who come for follow up regularly.
4.Subjects eligible for Matra vasti.
5.Tenderness along sciatic Nerve coarse
6.Radiating pain, starting from gluteal region towards foot
7.Sensory changes
8.Non-involvement of urinary bladder & rectum
9.Positive straight leg raising sign  
 
ExclusionCriteria 
Details  1.Subjects with the age below 20 years and above 60 years
2.Subjects with uncontrolled diabetes and hypertension
3.Subjects with pott’s spine
4.Subjects with Malignancy of spine
5.Traumatic lesson in lumbosacral region
6.Subjects underwent spinal surgeries
7.Subjects with pelvic pathology
8.Subjects who are using medications for Psychiatric disorders.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Relief in signs and symptoms of Pain, numbness, tingling sensation of Lower limbs  15 days 
 
Secondary Outcome  
Outcome  TimePoints 
Improves Digestion / Increases Appetite, decreases body heaviness  15 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/04/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  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 - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [upendrareddym1996@gmail.com].

  6. For how long will this data be available start date provided 15-03-2025 and end date provided 15-03-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   NEED FOR STUDY
At present, the life style is gradually shifting away from healthy living and therefore people fall victim of various disease. Sedentary life style, stress, improper posture, continuous jerky movements, long travelling etc put maximum pressure on spine and lower portion of pelvis. In spite of number of formulations and different kinds of procedures available for the treatment of Sciatica both in modern and ancient systems of medicines the incidence of disease is still increasing. 
 About 80 -90% of people get affected by low back pain and 5 % of those become victim of Sciatica . Men are affected a little more than women and are most frequent in the working individuals. High incidence is seen between 25-65 years. In treatment of Grdhrasi, the drug should have vatashamaka, kapha shamaka, vatanulomaka, Dipana- pachana and shula prasamana properties. Hence in this study effort is made to evaluate the Vishatindukadi vati and Asvagandhadya taila in the management of Grdhrasi vis-à-vis Sciatica.
 
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