| CTRI Number |
CTRI/2025/02/080201 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
01/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Agnikarma] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Agnikarma along with Payas (Sunthi Churna and Erand beej Churna) in Grudhrasi |
|
Scientific Title of Study
|
Clinical evaluation of Agnikarma along with payas made with Sunthi churna & Eranda beeja churna in management of Gridhrasi w.s.r 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 Deepali Sundari Verma |
| Designation |
Professor & Head |
| Affiliation |
Government Ayurvedic College |
| Address |
Department of Shalya Tantra, Government Ayurvedic College and Hospital
Kadamkuan
Patna
BIHAR
800003
India |
| Phone |
9430471341 |
| Fax |
|
| Email |
drdeepali261996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepali Sundari Verma |
| Designation |
Professor & Head |
| Affiliation |
Government Ayurvedic College |
| Address |
Department of Shalya Tantra, Government Ayurvedic College and Hospital
Kadamkuan
BIHAR
800003
India |
| Phone |
9430471341 |
| Fax |
|
| Email |
drdeepali261996@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepali Sundari Verma |
| Designation |
Professor & Head |
| Affiliation |
Government Ayurvedic College |
| Address |
Department of Shalya Tantra, Government Ayurvedic College and Hospital
Kadamkuan
BIHAR
800003
India |
| Phone |
9430471341 |
| Fax |
|
| Email |
drdeepali261996@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD-14, Government Ayurvedic College and Hospital Kadamkuan Patna Bihar India 800003 |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic College and Hospital Patna |
| Address |
Department of Shalya Tantra, Government Ayurvedic College and Hospital Kadamkuan Patna Bihar |
| 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 Divyaben Bharatbhai Vasava |
Government Ayurvedic College and Hospital, Patna |
OPD-14, Department of Shalya Tantra, Government Ayurvedic College and Hospital Kadamkuan Patna Bihar 800003
Patna
BIHAR |
7698606446
divyavsv192@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMITTEE, PATNA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M543||Sciatica. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sunthi Churna, Reference: Vangsen Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1.5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 35 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Erand Beej Churna, Reference: Vangsen Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1.5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 35 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Charak Samhita, Procedure details: Agnikarma we will use Panchdhatu salaka at site describe by our Carak acharya mentioned Agnikarma. In Gridhrsi at the site of Antara -kandara- Gulpha pradesha. From mid of medial aspect to the mid of lateral aspect of lower limbs covering the dorsal Surface at height of four angula from medial malleolus & lateral malleolus / Achilles tendon.)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Presence of Ruka, Toda, Stambha and Spandan in the Sphik, Kati, Uru, Janu, Jangha and Pada .
2. Local tenderness in lumber region and affacted lower limb.
3. Age group 30 to 70 yrs.
4. SLR test ,lasegue sign in affacted leg as the objective measures |
|
| ExclusionCriteria |
| Details |
1. People with paitika constitution where Agnikarma is contraindicated.
2. Patient below 16.
3. Pregnancy
4. Uncontrolled diabetes mellitus (diabetic neuropathy)
5. Multiple wound distributed at affected legs over ankle region .
6. Herpes simplex infection causing radiating pain |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in clinical sign and symptom (Pain, Tingling sensation, Pricking sensation, Walking distance, Stiffness, Numbness, Twitching, SLR Test, Lasegue sign) |
35 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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="1"
Days="5" |
|
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
|
For the management of sciatica various modalities are available like
conservative treatment (analgesics), epidural steroid injection, peri-radicular infiltration in modern medicine having their own limitations and
complications. Sushruta has mentioned Agnikarma as para-surgical procedures in
Gridhrasi as superior to other treatment modalities. The common
indications of thermotherapy include pain relief, stiffness, muscle spasm
and inflammatory conditions. These symptoms are observed in the patients
of sciatica. Hence considering above facts this study has been planned with
aim and objective to evaluate the effect of classical Agnikarma in the
management of Gridhrasi (sciatica). In Ayurvedic literature several methods of treatment like Snehana,
Upanaha, Agnikarma, Raktamoksana Panchakarma etc. are advised for
Vatik disease. Among these Agnikarma due to its Usna Suksma, Asukari
guna pacifies the Vata Kapha Dosa and removes Srotavarodha. Patient is
effectively relived from stiffness, pain and other associated symptoms.
Ayurvedacharya has mentioned various dravyas for Agnikarma procedure
but in this study panchadhatu salaka will be used. It is suitable for heat
transfer and to produce samyak dagdha vrana. To control the degenerative process rasayana, balya, vatasamak
amapachana drugs are suitable. To solve this problem Payasa making with
Sunthi churn & Eranda bija churn was selected for internal use to pacify the
vitiated vata kapha dosa. |