| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M478||Other spondylosis. Ayurveda Condition: ASTHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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 | | 2 | Intervention Arm | Procedure | - | | (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. |