| CTRI Number |
CTRI/2025/08/093697 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
30/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study to Evaluate the Efficacy and Safety of NERVE SANJEEVANI Ayurvedic Capsule in Patients with Sciatica Pain. |
|
Scientific Title of Study
|
A Non-randomized, Open-labelled, Clinical Study to Evaluate the Efficacy
and Safety of NERVE SANJEEVANI Ayurvedic Capsule in Patients with Sciatica Pain |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lokesh Holagundi |
| Designation |
Orthopaedic Surgeon |
| Affiliation |
Health India Hospital |
| Address |
Health India Hospital,
Orthopedic department, Room NO-02,Ground floor.
7, 6th Cross, Tavarekere Main Road, Chikka Adugodi, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
7760628844 |
| Fax |
|
| Email |
loksdoc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Kimtata |
| Designation |
Product Research Scientist |
| Affiliation |
ALNA BIOTECH PVT. LTD. |
| Address |
ALNA BIOTECH PVT. LTD.
Plot No. 21, HSIIDC, Industrial Estate
Alipur (Barwala), Panchkula
Haryana – 134118, India
Panchkula
HARYANA
134118
India |
| Phone |
9816333352 |
| Fax |
|
| Email |
vijaykimtata.vk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Hasan Ali Ahmed |
| Designation |
Director |
| Affiliation |
Xplora Clinical Research Services Pvt. Ltd. |
| Address |
Xplora Clinical Research Services Pvt Ltd.
Krishna Arcade, 3rd Floor,23, 5th Main, 12th Cross, Wilson Garden, Hombegowda Nagar, Bangalore-560027
Bangalore
KARNATAKA
560027
India |
| Phone |
9886012598 |
| Fax |
|
| Email |
hasan@xplorahealth.com |
|
|
Source of Monetary or Material Support
|
| ALNA BIOTECH PVT. LTD.
Plot No. 21, HSIIDC, Industrial Estate
Alipur (Barwala), Panchkula
Haryana – 134118, India.
|
|
|
Primary Sponsor
|
| Name |
ALNA BIOTECH PVT. LTD. |
| Address |
Plot No. 21, HSIIDC, Industrial Estate
Alipur (Barwala), Panchkula
Haryana – 134118, India.
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Lokesh Holagundi |
Healh India Hospital |
Orthopedic department, Room NO-02,Ground floor.
7, 6th Cross, Tavarekere Main Road, Chikka Adugodi, Bangalore
Bangalore
KARNATAKA |
7760628844
loksdoc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pranav Diabetes Center Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M543||Sciatica. Ayurveda Condition: VATAVYADHI^^ARISHTA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Nerve Sanjeevani , Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 650(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who meet all of the following criteria will be included in the study:
1)Adult male and female subjects aged 18-60 years.
2)Radiating pain into one leg below the knee, with a pain severity score of greater than 4 on a 0–10 Numeric Rating Scale (NRS) within the previous 24 hours.
3)Duration of pain must be at least 1 week and up to 6 months.
4)Presence of nerve root/spinal nerve involvement as indicated by at least one of the following:
a.Myotomal weakness.
b.Dermatomal sensory disturbances (e.g., tingling, numbness, sensory loss).
c.Diminished reflexes.
d.Leg pain radiating in a dermatomal distribution or exacerbated by a positive straight leg raise (SLR) test.
5)Ability and willingness to provide written informed consent.
6)Able to read and understand the local language used for study-related communication and materials.
|
|
| ExclusionCriteria |
| Details |
Participants will be excluded from the study if they meet any of the following conditions:
1)Known or suspected serious spinal pathology (e.g., cauda equina syndrome, spinal fracture).
2)Sciatica due to causes other than disc herniation or degenerative spinal stenosis.
3)Symptoms suggesting immediate need for surgery, including progressive large paresis or cauda equina syndrome.
4)Presence of neurogenic claudication (leg pain upon walking/standing relieved by sitting/lumbar flexion).
5)Scheduled or planned spinal surgery during the study period.
6)History of pregnancy, attempting to conceive, currently pregnant, or breastfeeding.
7)Subjects with liver or renal impairment, congestive heart failure, ischemic heart disease, peripheral arterial disease, or cerebrovascular disease.
8)Subjects with a history of peptic ulceration, gastrointestinal bleeding, or perforation.
9)Use of medications (e.g., Anticoagulants, Aspirin, NSAIDs Selective Serotonin Reuptake Inhibitors, Systemic corticosteroids), food or herbal supplements within 30 days from the date of screening.
10)Use of diuretics, ACE inhibitors, or lithium.
11)Ongoing psychiatric illness, drug or alcohol abuse, or any condition that may interfere with adherence to the study protocol or follow-up.
12)Known hypersensitivity to any ingredient of the NERVE SANJEEVANI Capsule.
13)Non-compliance or inability to follow the study protocol, as judged by the investigator.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in sciatica pain intensity (in the last 24 h) assessed by the Numeric Rating Scale (NRS) score from baseline to different study visits |
Day-1 (Screening visit)
Day-14 (End of visit) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in Disability, assessed by the Roland Morris
Disability Questionnaire for Sciatica (RMDQ-S) from
baseline and end of treatment.
Change in Sciatica symptom severity, assessed by the
Sciatica Bothersomeness Index (SBI) from baseline to end
of visits.
Rescue medication consumption, measured by pill count,
i.e., the number of paracetamol pills not returned at the final
study visit.
Change in Global perceived change (GPC), measured on a
verbal rating scale: sciatica/back problem “completely
gone”, “much better”, “better”, “a little better”, “no change”, “a little worse”, “worse”, or “much worse”.
Change in Health-Related Quality of Life (HRQOL) using
the SF-36 Score. |
Day-1 (Screening visit)
Day-14 (End of visit) |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
08/09/2025 |
| Date of Study Completion (India) |
27/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Sciatica, characterized by radiating pain along the sciatic nerve pathway from the lower back
into the leg, is a prevalent and debilitating condition often caused by lumbar disc herniation
or spinal stenosis.Sciatica pain, often persistent and resistant to conventional therapies, significantly affects
patients’ quality of life and functional ability. While pharmacological management including
NSAIDs, corticosteroids, and surgical interventions are standard approaches, these options
are often associated with limited long-term efficacy or adverse effects. The dosage of NERVE SANJEEVANI Capsule (650 mg twice daily) has been selected based
on authoritative Ayurvedic texts and traditional clinical practice. Primary Objective: To evaluate the clinical efficacy of NERVE SANJEEVANI Capsule in reducing sciatica pain
intensity using the Numerical Pain Rating Scale. Secondary Objectives
The secondary objectives of this study are to: 1.Improvement in disability
2) Global perceived improvement
3) Improvement in sciatica symptom severity
4) Use of rescue medication (paracetamol) consumption
5) Safety and tolerability of NERVE SANJEEVANI Capsule The treatment continues for a period of 14 days (2 weeks). The total duration of the study is 6
months. A total of 50 adult subjects will be enrolled in the
study group (NERVE SANJEEVANI Capsule) based on practical feasibility, clinical
judgment, and prior experience with similar studies. The chosen sample size is considered
adequate to provide preliminary insights into the efficacy and safety profile of the
investigational product in patients with sciatica pain. The schedule of assessment for this study spans a duration of 14 days (2 weeks) and
comprises three visits: the screening visit & baseline visit (V1), and end-of-study visit (V2). Baseline and End of visit evaluations will include the Numeric Rating Scale (NRS) for pain, the Roland Morris
Disability Questionnaire for Sciatica (RMDQ-S), the Sciatica Bothersomeness Index (SBI),
Global Perceived Change (GPC) and the Short Form-36 (SF-36) health-related quality of life questionnaire. Blood samples will be collected for safety laboratory tests including complete
blood count (CBC), SGPT, SGOT, Serum creatinine and Random blood sugar levels. |