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CTRI Number  CTRI/2025/09/094613 [Registered on: 11/09/2025] Trial Registered Prospectively
Last Modified On: 11/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study the effect of Adityapak Guggul and Karpasasthyadi Sweda in Lumbar Spondylosis. 
Scientific Title of Study   A Clinical Study To Evaluate The Efficacy Of Adityapak Guggul And Karpasasthyadi Sweda In Asthimajjagata Vata (Lumbar 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 Anushree Abhay Savarkar 
Designation  PG Scholar, Dept. of Kayachikitsa 
Affiliation  Bharateeya Sanskriti Prabodhinis Gomantak Ayurved Mahavidyalaya And Research Centre 
Address  Department of Kayachikitsa, Bharateeya Sanskriti Prabodhinis Gomantak Ayurved Mahavidyalaya And Research Centre, Shiroda , Tal.Ponda, Dist. North Goa,403103
Dept. of Kayachikitsa, Sanskriti Prabodhinis Gomantak Ayurved Mahavidyalaya And Research Centre , Tal.Ponda,Dist.North Goa,403103
North Goa
GOA
403103
India 
Phone  9423025487  
Fax    
Email  anushreeras98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mithun Bondre 
Designation  Guide and Associate Professor , Dept. Of Kayachikitsa 
Affiliation  Bharateeya Sanskriti Prabodhinis Gomantak Ayurved Mahavidyalaya And Research Centre 
Address  Dept. Of Kayachikitsa,Bharateeya Sanskriti Prabodhinis Gomantak Ayurved Mahavidyalaya And Research Centre, Vazem,Shiroda ,Tal.Ponda, Dist.North Goa,403103
Dept. Of Kayachikitsa,Bharateeya Sanskriti Prabodhinis Gomantak Ayurved Mahavidyalaya And Research Centre, Vazem,Shiroda ,Tal.Ponda, Dist.North Goa,403103
North Goa
GOA
403103
India 
Phone  9823170774  
Fax    
Email  mithunbondre23@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  DrAnushree Abhay Savarkar 
Designation  PG Scholar,Dept. of Kayachikitsa 
Affiliation  Bharateeya Sanskriti Prabodhinis Gomantak Ayurved Mahavidyalaya And Research Centre 
Address  Dept. Of Kayachikitsa,Bharateeya Sanskriti Prabodhinis Gomantak Ayurved Mahavidyalaya And Research Centre, Vazem,Shiroda ,Tal.Ponda, Dist.North Goa,403103
Dept. Of Kayachikitsa,Bharateeya Sanskriti Prabodhinis Gomantak Ayurved Mahavidyalaya And Research Centre, Vazem,Shiroda ,Tal.Ponda, Dist.North Goa,403103
North Goa
GOA
403103
India 
Phone  9423025487  
Fax    
Email  anushreeras98@gmail.com  
 
Source of Monetary or Material Support  
Bharateeya Sanskriti Prabodhinis Gomantak Ayurved Mahavidyalaya And Research Centre,Goa 
 
Primary Sponsor  
Name  Dr Anushree Abhay Savarkar 
Address  Dept.Of Kayachikitsa,Bharateeya Sanskriti Prabodhinis Gomantak Ayurved Mahavidyalaya And Research Centre, Vazem,Shiroda ,Tal.Ponda, Dist.North Goa,403103 
Type of Sponsor  Other [self] 
 
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 
DrAnushree Abhay Savarkar  BSPs Gomantak Ayurved Mahavidyalaya And Research Centre and Kamakshi Aarogyadham  Dept. Of Kayachikitsa,Bharateeya Sanskriti Prabodhinis Gomantak Ayurved Mahavidyalaya And Research Centre, Vazem,Shiroda ,Tal.Ponda, Dist.North Goa,403103
North Goa
GOA 
9423025487

anushreeras98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bharateeya Sanskriti Prabodhinis Gomantak Ayurved Mahavidyalaya And Research Centre - Institutional ethics committee   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: ASTHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Adityapak guggul , Reference: Vangasen Vatavyadhi adhikar 214-216, Chakradatta Vatavyadhi adhikar 66-68, Gadanigraha vatavyadhi adhikar 157-159, Route: Oral, Dosage Form: Guggulu , Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Koshna jala), Additional Information: 2 tablets( weighing 500mg each) BID , after food with 12 hours gap in between with koshna jala
2Intervention ArmProcedure- (Procedure Reference: , Procedure details: )
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients with classical sign and symptoms of Asthimajjagata vata.
BMD value less than-1.
patients of either gender.
patients in the age group 18-70 years
 
 
ExclusionCriteria 
Details  Patients not willing to participate in trial and not given consent.
Patients suffering from chronic systemic diseases like TB, Cancer, and on medications and or history of recent surgery, trauma, fractures.
Pregnancy
Patients with major neurological deficit(ex. MND)
Patients with spine deformities, Myelopathy, Potts spine, Kyphosis, Spinal stenosis, Spondylolisthesis etc.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To observe the changes before and after treatment in patients of Asthimajjagata vata(Lumbar spondylosis) in terms of Classical symptoms like Shool(pain), Stambha(stiffness), Kriyakashtata, Daurbalya (weakness),Anidra, Saushirya .  after 1 month 
 
Secondary Outcome  
Outcome  TimePoints 
To observe changes before & after treatment in patients of Asthimajjagata vata in terms of Pain, Localized stiffness, Range of movements(Goniometry), Sleep quality,weakness & BMD value  after one month 
 
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)   22/09/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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   This study and clinical trial named A Clinical Study to evaluate The Efficacy Of Adityapak Guggul and Karpasasthyadi Sweda In Asthimajjagata Vata (Lumbar Spondylosis) is a part of Postgraduate studies in Kayachikitsa (MD Kayachikitsa).
Ayurveda briefs about various preventive and therapeutic aspects to maintain good health along with various diseases, their pathophysiology and detail treatment, Vatavyadhi are some of them. In present era, young as well as elderly patients with Lower back pain, difficulty in performing daily activities are commonly seen in hospitals, OPDs. Overall lifestyle changes and age related degenerative changes are two main Hetu of the disease which lead to vitiation of Vata dosha, Asthivaha and Majjavaha srotas leading to Asthi and Sandhi shool, Saushirya Bheda, Kriyakashtata, Daurbalya, Anidra that is Asthimajjagata vata. This Samprapti very commonly occurs in Kati pradesh i.e. Lumbar (Lumbosacral)region leading to lumbar spondylosis.

Many medicines and treatment protocols are described in Ayurveda texts under the heading of Vatavyadhi chikitsa. Adityapak guggul, described by Vangasena samhita (Vangasene samhita Vatavyadhi adhikar 214-216). Chakradatta (Chakradatta Vatavyadhi chikitsa 66-68), Gadanigraha (Vatavyadhi adhikar 157-159) is the Kalpa which is not very commonly prescribed needs to be authenticate with scientific research. The contents including triphala which is Kapha-pittaghna, sara, rasayana, anulomak rest contents like Twak Ela, Pippali and Dashamool, guggul are Ushna Vataghna. Together they perform Anuloman and regulation of Vata gati thereby controlling degenerative changes, also, anti-inflammatory and analgesic action and hence effective in Asthimajja vikar

Karpasasthyadi sweda is mentioned in Shooladhikar for pain in Janu, Sphik, Kati region, where it is said to be pacifying shoola completely Swedana procedure is Kapha-vataghna, shoolaghna by pacifying Vata dosha and Margavarodha Hence this procedure will also help the patients get relief from pain and stiffness and providing ease of movements

this study is interventional, controlled open labelled, randomized study in minimum 30 patients, 15 in each group where in one group Adityapak guggul will be given orally in dose 1gm BID in Vyanodan kala (after food with 12 hours gap) for 30 days 200, will be even oral medication of 30 days along with Swedan procedure for 7 days Assessment will he done on first, seventh and 31th day.
patients will be assessed on the basis of classical symptoms of Asthimajjagata vata which are Shoola, Stambha, Kriyakashtata Anidra Bheda, Daurbalya along with Pain scale (VAS scale), stiffness scale, range of movements, sleep scale oswestry low back pain disability questionnaire and BMD value. Patients in between the age group of 18-70years and of either gender will be selected. Patients not willing to participate or not given written consent, pregnant females also patients with chronic illness such as Tb, cancers, recent surgical history, fractures, myelopathy, spine deformities etc. will be excluded. the entire study will be completed in the period of one and half years in which trial will be completed within period of 6-8 months.
 
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