| CTRI Number |
CTRI/2026/01/102575 [Registered on: 30/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to assess the added benefit of Ashtapad Rajat Shalaka Agnikarma in relieving low back pain in patients with lumbar spondylosis |
|
Scientific Title of Study
|
Randomised controlled clinical trial to evaluate the add on effect of asthapad rajat shalaka agnikarma in management of katigat vata w.s.r. to 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 Sandeep Rajendra Girase |
| Designation |
PG Scholar MS Shalyatantra |
| Affiliation |
MES AYURVED MAHAVIDYALAYA |
| Address |
OPD NO 9 PARSHURAM HOSPITAL MES AYURVED MAHAVIDYALAYA GHANEKHUNT LOTE KHED
Ratnagiri
MAHARASHTRA
415722
India |
| Phone |
8669146656 |
| Fax |
|
| Email |
girasesandip9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh Shankarrao Borase |
| Designation |
HOD & Professor MS Shalyatantra |
| Affiliation |
MES AYURVED MAHAVIDYALAYA |
| Address |
OPD NO 9 PARSHURAM HOSPITAL MES AYURVED MAHAVIDYALAYA GHANEKHUNT LOTE KHED
Ratnagiri
MAHARASHTRA
415722
India |
| Phone |
8329008455 |
| Fax |
|
| Email |
dryogeshborase@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Rajendra Girase |
| Designation |
PG Scholar MS Shalyatantra |
| Affiliation |
MES Ayurved Mahavidyalaya |
| Address |
OPD NO 9 PARSHURAM HOSPITAL MES AYURVED MAHAVIDYALAYA GHANEKHUNT LOTE KHED
Ratnagiri
MAHARASHTRA
415722
India |
| Phone |
8669146656 |
| Fax |
|
| Email |
girasesandip9@gmail.com |
|
|
Source of Monetary or Material Support
|
| MES Ayurved Mahavidyalaya & attached Parshuram Hospital & Research centre, Ghanekhunt Lote, Khed Ratnagiri Maharashtra India -415722 |
|
|
Primary Sponsor
|
| Name |
Dr Sandeep Rajendra Girase |
| Address |
OPD NO 9 PARSHURAM HOSPITAL MES AYURVED MAHAVIDYALAYA GHANEKHUNT LOTE KHED |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Sandeep Rajendra Girase |
MESAM Parshuram Hospital |
OPD NO 9 PARSHURAM HOSPITAL MES AYURVED MAHAVIDYALAYA GHANEKHUNT LOTE KHED
Ratnagiri
MAHARASHTRA |
8669146656
girasesandip9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MES Ayurved Mahavidyalaya ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M471||Other spondylosis with myelopathy. Ayurveda Condition: VATAVYADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Dashmularistha , Reference: Bhaishajyaratnavali vatvyadhi chikitsa 26/266-270, Route: Oral, Dosage Form: Arishta, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: -(2) Medicine Name: Yograj guggul , Reference: Bhaishajyaratnavali Aamvat chikitsa 29/ 63-70, Route: Oral, Dosage Form: Guggulu , Dose: 2(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: - | | 2 | Intervention Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Sushrut samhita,sutrasthan 12/10, Procedure details: Whole procedure was under three steps, Purva, Pradhana and Paschat Karma
Purva Karma :-
The patients will explain about the management procedure.
Written consent will taken from every patient before hand.
The patient should be adviced to eat before the procedure.
Patients will ask to be in sitting position over the minor OT table.
Lumbar region will be clean and dry with sterilized gauze piece.
The most tender point will be mark with a marker in the lumbar region.
Pradhana Karma :-
Ashtapad Rajat shalaka will be hold with artery forceps.
Ashtapada end of Shalaka will be place on the site of lumbar pain and
the other end will burn with the lighter to produce continuous heat.
After heat sensation,Shalaka will be remove and place on other site of
pain and tenderness.
Pashchat Karma:-
Immediately after Agnikarma, jatyadi ghrut will applied on the site of
Agnikarma to avoid burning scar and other adverse effects.
The patient will be advise to take rest for 10 minutes and will sent
home.
The patient will be advice to avoid dietic regimen which aggravates
Vata Kapha like potato, rice,brinjal, pumpkin, etc.
Number of sittings: Two such sittings of Agnikarma was carried out on 0th
day,
7
th
day with a gap of 7 days each (if pain diminish before 2 setting it will also
be included in the study).
)
(1) Medicine Name: Dashmularistha , Reference: Bhaishajyaratnavali,vatvyadhi chikitsa 26/266-270, Route: Oral, Dosage Form: Arishta, Dose: 15(ml), Frequency: bd, Duration: 10 Days(2) Medicine Name: Yograj Guggulu, Reference: Bhaishajyaratnavali Aamvat chikitsa 29/63-70, Route: Oral, Dosage Form: Guggulu, Dose: 2(NA), Frequency: bd, Duration: 10 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinical features of Katigata Vata / lumbar spondylosis confirmed by Xray
Patients of either sex between 30 to 60 years.
Willing & able to participate and complete the study.
Selection will be irrespective of gender, religion and other socioeconomic status |
|
| ExclusionCriteria |
| Details |
History of spinal surgery, fractures, malignancy, or systemic illness
Pregnant and lactating women
Tuberculosis of spine
Contraindications for Agnikarma (skin disorders, bleeding disorders,
uncontrolled diabetes, etc.) |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of Ashtapad Rajat Shalaka Agnikarma in reducing pain,
stiffness, and improving functional status in Katigata Vata with special
reference to lumbar spondylosis. |
10 days study with follow up on 7th & 10th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in stiffness of the lower back.
Improvement in range of movements of the lumbar spine.
Reduction in tenderness over the lumbosacral region.
Improvement in functional ability & daily activities.
Reduction in associated symptoms such as radiating pain.
Decrease in requirement of analgesic medications.
Improvement in quality of life score. |
10 days study with follow up on 7th & 10th day. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/02/2026 |
| 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)
|
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 - NO
|
|
Brief Summary
|
Title - RANDOMIZED CONTROLLED CLINICAL TRIAL TO EVALUATE THE ADD ON
EFFECT OF ASHTAPAD RAJAT SHALAKA AGNIKARMA IN MANAGEMENT OF
KATIGAT VATA W.S.R.TO LUMBAR SPONDYLOSIS.
Null hypothesis [H0] - Ashtapad rajat shalaka agnikarma is not significantly effective in katigata vata
with special reference to lumbar spondylosis .
Alternate hypothesis [H1] - Ashtapad rajat shalaka agnikarma is significantly effective in katigata vata
with special reference to lumbar spondylosis.
Study design - Randomized controled clinical trial
Inclusion criteria - Clinical features of Katigata Vata / lumbar spondylosis confirmed by Xray Patients of either sex between 30 to 60 years. Willing & able to participate and complete the study. Selection will be irrespective of gender, religion and other socioeconomic status.
Exclusive criteria- History of spinal surgery, fractures, malignancy, or systemic illness Pregnant and lactating women Tuberculosis of spine Contraindications for Agnikarma (skin disorders, bleeding disorders, uncontrolled diabetes, etc.)
Sample size- 70 (35 for each group)
Sample population - Patients coming to OPD, IPD parent ayurveda rugnalaya and camps in the periphery of parent research center and hospital with Katigata vata(Lumbar spondylosis)
Group A- Yograj guggul vati + Dashmularistha +Ashtapad Rajat Shalaka agnikarma
Group B- Yograj guggul vati + Dashmularistha
Total duration of therapy is 10 days. The mode of drug administration will be oral route and local agnikarma therapy
Follow up - Follow up will be on 7th ,10th day
Result - Result will be drawn as per assessment criteria and statistical analysis.
|