| CTRI Number |
CTRI/2025/12/098785 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
10/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effect of Gomutrayukta Erand Tail Basti and its oral administration in two group of 20 patients of Gridhrasi w.s.r. to Sciatica |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of Gomutrayukta Erand Tail Basti and its oral administration in the management of Gridhrasi w.s.r. to 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 Ajay Kumar |
| Designation |
MD(Ay.) Scholar(Dept. of Panchakarma) |
| Affiliation |
Government Ayurvedic College and Hospital |
| Address |
Dept. of Panchakarma, Govt. Ayurvedic College and Hospital, Near Buddha Murti, Kadamkuan
Patna
Patna
BIHAR
800003
India |
| Phone |
9122709224 |
| Fax |
|
| Email |
drajaykumar2023@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akhilesh Prasad Singh |
| Designation |
Asso. Prof. Dept. of Panchakarma |
| Affiliation |
Government Ayurvedic College and Hospital |
| Address |
Dept. of Panchakarma,
Govt. Ayurvedic College and Hospital,
Near Buddha Murti, Kadamkuan
Patna
Patna
BIHAR
800003
India |
| Phone |
8002680973 |
| Fax |
|
| Email |
drapsinghpatna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akhilesh Prasad Singh |
| Designation |
Asso. Prof. Dept. of Panchakarma |
| Affiliation |
Government Ayurvedic College and Hospital |
| Address |
Dept. of Panchakarma,
Govt. Ayurvedic College and Hospital,
Near Buddha Murti, Kadamkuan
Patna
Patna
BIHAR
800003
India |
| Phone |
8002680973 |
| Fax |
|
| Email |
drapsinghpatna@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College and Hospital, Near Buddhmurti, Kadamkuan, Patna, Bihar- 800003 |
|
|
Primary Sponsor
|
| Name |
Dr Ajay Kumar |
| Address |
Dept. of Panchakarma
Government Ayurvedic College and Hospital, Near Buddhmurti, Kadamkuan, Patna, Bihar-800003 |
| 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 |
| Dr Ajay Kumar |
Government Ayurvedic College and Hospital |
OPD No. 11
Dept. of Panchakarma, Govt. Ayurvedic College and Hospital, Near Buddha Murti, Kadamkuan
Patna
Patna
BIHAR |
09122709224
drajaykumar2023@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee(IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G00-G99||Diseases of the nervous system. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: EARAND TAILA, Reference: CHAKRADATTA, Route: Oral, Dosage Form: Taila, Dose: 24(ml), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Gomutra), Additional Information: - | | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: CHARAK SAMHITA, Procedure details: After snehan swedan on kati pradesh(pelvic region) basti dravya( gomutrayukt erand tail) will be administered through anal route)
(1) Medicine Name: Erand taila, Reference: Charak samhita, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
The presence of Ruka, Toda, Stambh and Spandan in the Sphik, Kati, Uru, Janu
Jangha and Pada.
Tenderness along Sciatica nerve.
Patient of either sex between age group 20-70 years will be included.
SLR test in affected leg as objective measure for diagnosis and assessment will be
taken.
|
|
| ExclusionCriteria |
| Details |
Contraindicated for Oral administration of Gomutrayukta Erand Taila and Basti.
Known cases of any major illness i.e. DM, TB, AIDS, Covid-19 and Malignancy.
Surgical indication such as progressive neurological deficit.
Pregnancy, Anemia, Gout, Leprosy, Kamala, Atisar.
Age below 20 years and above 70 years
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Relief in sign and symptom of gridhrasi i.e. Ruk(pain), Stambh(Stiffness),Toda(pricking sensation), Aruchi(anorexia), Tandra(lethargy), Gaurav(heaviness).
2. Relief in low back pain symptoms like pulling pain, stiffness, pricking sensation |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SLR Test |
60 days |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 |
|
Date of First Enrollment (India)
|
02/02/2026 |
| 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="0"
Months="8"
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
|
This study is a Randomized open, parallel group, interventional, prospective trial to compare and to evaluate the efficacy of Gomutrayukta Erand Taila Basti and its oral administration in the management of Gridhrasi w.s.r to Sciatica conducted in Govt. Ayurvedic college and Hospital Kadamkuan, Patna , Bihar in the Dept. of Panchakarma . In Group A of 20 patients , Basti karm will be performed with Gomutrayukt Erand Tail for 30 days days. In Group B of 20 patients Gomutrayukt Erand Tail will be orally administerd for 30 days. , |