| CTRI Number |
CTRI/2026/01/100918 [Registered on: 13/01/2026] Trial Registered Prospectively |
| Last Modified On: |
02/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Marma therapy , Agnikarma] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Study of Knee Pain and the Effect of Traditional Treatments like Marma Therapy and Agnikarma |
|
Scientific Title of Study
|
A Critical Study of Janu Sandhi and Janu Marma with evaluation of the effect of Marma Therapy and Agnikarma in Cases of Osteoarthritis of Knee Joint |
| 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 Anjali Patel |
| Designation |
MD Scholar |
| Affiliation |
Institute of Medical Science Banaras Hindu University |
| Address |
Department of Rachana Sharir Faculty of Ayurveda IMS BHU Varanasi 221005 U.P. India
Department of Rachana Sharir Faculty of Ayurveda IMS BHU Varanasi 221005 U.P. India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
07610320250 |
| Fax |
|
| Email |
anjali291patel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashutosh Kumar Pathak |
| Designation |
Assistant professor |
| Affiliation |
Institute of Medical Science Banaras Hindu University |
| Address |
Department of Rachana Sharir Faculty of Ayurveda IMS BHU Varanasi 221005 U.P. India
Department of Rachana Sharir Faculty of Ayurveda IMS BHU Varanasi 221005 U.P.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415812548 |
| Fax |
|
| Email |
drpathakbhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashutosh Kumar Pathak |
| Designation |
Assistant professor |
| Affiliation |
Institute of Medical Science Banaras Hindu University |
| Address |
Department of Rachana Sharir Faculty of Ayurveda IMS BHU Varanasi 221005 U.P. India
Department of Rachana Sharir Faculty of Ayurveda IMS BHU Varanasi 221005 U.P.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415812548 |
| Fax |
|
| Email |
drpathakbhu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of orthopedic IMS BHU |
|
|
Primary Sponsor
|
| Name |
Banaras Hindu University |
| Address |
Department of Rachana Sharir, Faculty of Ayurveda IMS BHU Varanasi, Uttar Pradesh
Pin- 221005 UTTAR PRADESH 221005 India Sir Sundarlal Hospital IMS BHU Varanasi,
UTTAR PRADESH
Address
Varanasi
UTTAR PRADESH
221005
India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anjali Patel |
department of orthopedic,trauma center,BHU,Varanasi |
Department of Rachana Sharir Faculty of Ayurveda IMS BHU Varanasi 221005 U.P. India
Varanasi
UTTAR PRADESH |
07610320250
anjali291patel@gmail.com |
| Dr Anjali Patel |
Trauma center |
Room no.06,
Department of orthopaedic,
Varanasi
UTTAR PRADESH |
7610320250
anjali291patel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Banaras Hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | marmacikitsA agnikarma | (Procedure Reference: Suhsruta Samhita, sharir sthan chapter 6, sholka- 15, suhsruta Samhita ,sharir sthan chapter 6 , shloka -34 ,35-36. suhsruta Samhita, sutra sthana chapter 12, shloka -3,4,10,11 suhsruta Samhita, sharir sthan chapter 8,shloka-9 Dr.R.B Gogate,Viaddha and Agni karma chikitsha, 5th edition Gogate memorial foundation ,pune page no.19,21,23,24,57., Procedure details: 1. Marma Therapy
Marma Points:
Janu, Gulpha, & Kshipra Marma
Preparation
1. Patient will be made to sit or lie down comfortably.
2. Knee & surrounding area will be exposed.
Procedure
a. Gulpha Marma Stimulation
1. Ankle will be held with thumb.
2. Index finger will be used like a hook to apply pressure.
3. Press–lift–release technique will be done.
4. Stimulation will be performed 5–8 times/min for 1 minute.
b. Kshipra Marma Stimulation
1. Leg will be kept straight.
2. First toe will be bent to identify the tender area near the head of the first metatarsal.
3. The identified tender point will be stimulated.
4. Stimulation will be done in coordination with breathing, 15–18 times/min for 1 minute.Agnikarma Points
1. Medial aspect of base of patella
2. Lateral aspect of base of patella
3. Medial aspect of apex of patella
4. Lateral aspect of apex of patella
5. Most tender points of knee joint
6. Area just above Kshipra Marma
Preparation
1. Patient will be explained about the procedure.
2. Patient will be seated or lying comfortably.
3. Affected knee will be cleaned with Betadine and draped.
Procedure
1. Red-hot Shalaka will be applied for less than one second at identified points.
2. Bindu Vishesha technique will be used.
3. 4–6 points will be treated in one sitting.
4. Proper signs of Samyak Dagdha (Kapot Varna) will be ensured.
5. Procedure will be done once every 2 weeks for 8 weeks.
Post-Procedure Care
1. Cooling with Aloe Vera (Kumari) gel or Ghee will be applied.
2. The area will be kept dry and not washed for 24 hours.
⸻
Follow-Up and Assessment
1. Follow-up visits will be done every 2 weeks.
2. Patients will be monitored for any adverse effects.
3. Assessment will be done using:
• VAS scale
• WOMAC scale
• SF-36 Quality of Life scale
4. Evaluation will be done before treatment, during each follow-up, and after completion of therapy.
)
(1) Medicine Name: yograj guggulu, Reference: sharangdhara samhita madhyam khand 7/62, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 12(g), Frequency: bd, Duration: 2 Months | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: yograj guggulu , Reference: sharangdhara samhita madhyam khand 7/62 , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: -yograj guggulu two time a day for two month | | 3 | Comparator Arm (Non Ayurveda) | | - | drug | oral analgesic drug(etoricoxib 90mg sos) |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 40 years and older who have chronic knee pain (for more than 6 months) and diagnosed with KOA according to the American College of Rheumatology (ACR) diagnostic criteria or
Patients till stage 4 OA in both knees according to Kellgren Lawrence (KL) criteria will be included in the study.
|
|
| ExclusionCriteria |
| Details |
Patients with previous knee surgery;
Those who have had intraarticular injection (steroid, prolotherapy, platelet-rich plasma, etc.),
Acupuncture, or physiotherapy in the last 6 months;
Patients with rheumatoid arthritis or other inflammatory joint diseases,
Autoimmune, and rheumatic diseases;
Secondary KOA;
Senile dementia
Severe psychiatric and psychological disorders;
Allergic skin diseases,
Ulcer, or infection;
Pregnant and lactating patients
Patients receiving anticoagulant therapy;
Hearing aids or pacemakers;
Abnormal hepatic or renal dysfunction;
Neuropathic pains will be excluded
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in symptoms of osteoarthritis |
change in symptoms of osteoarthritis Outcomes will be assessed at the following specific time points:
• Baseline (Week 0) – before starting treatment
• Week 4 – mid-treatment assessment
• Week 8 – post-treatment / final assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduction in WOMAC Scale and VAS scale and increase in QOL Scale |
60 day study with follow up every two week |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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)
|
22/01/2026 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This prospective comparative clinical study will include 108 patients with knee osteoarthritis, randomly divided into three groups of 36 each. The first group will receive standard analgesic treatment, the second group will receive Marma Therapy and Agnikarma along with Yograj Guggulu, and the third group will receive only Yograj Guggulu. Outcomes related to pain relief, functional improvement, and quality of life will be evaluated to assess and compare the therapeutic effectiveness of these treatment modalities in knee osteoarthritis. |