| CTRI Number |
CTRI/2024/12/078363 [Registered on: 20/12/2024] Trial Registered Prospectively |
| Last Modified On: |
06/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Nirgundi Kashayam and Parijata Kashayam for Sciatica |
|
Scientific Title of Study
|
Comparative Pharmacognostical and Clinical Study of Parijata (Nyctanthes arbor-tristis Linn) and Nirgundi (Vitex negundo Linn) as Vedanahara in Gridhrasi with Special Reference 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. Pola Karthikeya |
| Designation |
PG Scholar |
| Affiliation |
Dr. BRKR Government Ayurvedic College |
| Address |
Dr. BRKR Government Ayurvedic College
Opposite ESI Hospital, Towards S R Nagar,
AG Colony Road, Sultan Nagar, Erragadda,
Hyderabad, Telangana - 500018.
Hyderabad
TELANGANA
500018
India |
| Phone |
8019339168 |
| Fax |
|
| Email |
developer.beingvaidya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. S. Baburao |
| Designation |
Associate professor |
| Affiliation |
Dr. BRKR Government Ayurvedic College |
| Address |
Dr. BRKR Government Ayurvedic College
Opposite ESI Hospital, Towards S R Nagar,
AG Colony Road, Sultan Nagar, Erragadda,
Hyderabad, Telangana - 500018.
Hyderabad
TELANGANA
500018
India |
| Phone |
9885361326 |
| Fax |
|
| Email |
hayagrivavedatarupvtltd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. S. Baburao |
| Designation |
Associate professor |
| Affiliation |
Dr. BRKR Government Ayurvedic College |
| Address |
Dr. BRKR Government Ayurvedic College
Opposite ESI Hospital, Towards S R Nagar,
AG Colony Road, Sultan Nagar, Erragadda,
Hyderabad, Telangana - 500018.
Hyderabad
TELANGANA
500018
India |
| Phone |
9885361326 |
| Fax |
|
| Email |
hayagrivavedatarupvtltd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. BRKR Government Ayurvedic College
Opposite ESI Hospital, Towards S R Nagar,
AG Colony Road, Sultan Nagar, Erragadda,
Hyderabad, Telangana - 500018. |
|
|
Primary Sponsor
|
| Name |
Dr BRKR Government Ayurvedic College |
| Address |
Opposite ESI Hospital, Towards S R Nagar,
AG Colony Road, Sultan Nagar, Erragadda,
Hyderabad, Telangana - 500018. |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Central Council for Research in Ayurvedic Sciences CCRAS |
Education Cell, CCRAS, 61-65, opp. D Block, Institutional Area, Janakpuri, New Delhi - 110058 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pola Karthikeya |
Dr BRKR Government Ayurvedic College |
Dr BRKR Government Ayurvedic College, Department of Dravyaguna, Ground floor OP room no 4, Opp ESI Hospital ,towards S R Nagar, AG Colony Rd, Sultan Nagar, Erragadda, Hyderabad, Telangana 500018
Hyderabad
TELANGANA |
8019339168
developer.beingvaidya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government of Telangana Dr. BRKR Government Ayurvedic College, Erragadda, Hyderabad Affiliated to Kaloji Narayana Rao University of Health Sciences, Warangal, Telangana Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G55||Nerve root and plexus compressionsin diseases classified elsewhere. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Parijata Kashayam , Reference: Priya Nighantu 80/190, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nirgundi Kashayam , Reference: Bhavaprakasha Nighantu 3/113, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age between 20-60 years, irrespective of gender, caste, religion and socioeconomic status were selected for study
Patients suffering with Low back ache radiating to lower limbs
Patients presenting with lakshanas of gridhrasi |
|
| ExclusionCriteria |
| Details |
Patients suffering with below mentioned conditions will be excluded
Uncontrolled Diabetes Mellitus and Hypertension
Loss of bowel and bladder control
Spondylolisthesis
Vertebral Fractures
Foot drop
Psychiatric disorders
Pott’s spine
Post spinal surgical cases
Severe systemic disorders
Malignancy |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome of study is:
Reduction in pain levels in patients with Gridhrasi (Sciatica).
Measured using: Visual Analog Scale (VAS) & other parameters.
|
The time points for the study are as follows:
1. Baseline Assessment:
Conducted on Day 1 before starting the treatment.
2. Duration of Treatment:
The treatment will be administered for 45 days.
3. Patient Reviews:
Patients will be reviewed every 15 days during the treatment period (i.e., on Day 15, Day 30, and Day 45).
4. Follow-Up:
A follow-up assessment will be conducted 30 days after completing the treatment.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Functional improvement
2) Reduction in inflammation
3) Improvement in Range of motion
4) Patient satisfaction
|
The time points for the study are as follows:
1. Baseline Assessment:
Conducted on Day 1 before starting the treatment.
2. Duration of Treatment:
The treatment will be administered for 45 days.
3. Patient Reviews:
Patients will be reviewed every 15 days during the treatment period (i.e., on Day 15, Day 30, and Day 45).
4. Follow-Up:
A follow-up assessment will be conducted 30 days after completing the treatment. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
Modification(s)
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
"Comparative Pharmacognostical and Clinical Study of Parijata (Nyctanthes arbor-tristis Linn) and Nirgundi (Vitex negundo Linn) as Vedanahara in Gridhrasi W.S.R to Sciatica", aims to compare the efficacy and safety of two herbal treatments—Parijata (Nyctanthes arbor-tristis) and Nirgundi (Vitex negundo)—in the management of Gridhrasi (Sciatica), which is a common cause of lower back and leg pain.
Study Objectives:
Pharmacognostical Comparison: To analyze the pharmacological properties, active constituents, and quality of the two herbs.
Clinical Comparison: To evaluate the therapeutic effects of Parijata and Nirgundi in treating sciatica symptoms, including pain relief, functional improvement, and quality of life.
Study Design:
A randomized, parallel group, active control trial where participants will be assigned to receive either Parijata, Nirgundi, or a standard treatment.
Primary Outcomes:
Pain reduction using tools like the Visual Analog Scale (VAS)
Functional improvement through disability assessments
Secondary Outcomes:
Reduction in inflammation, assessed by CRP levels.
Improvement in range of motion by SLR TEST
Tracking of adverse effects and patient satisfaction.
Conclusion:
The study will help determine the effectiveness of these two herbal treatments in reducing sciatica symptoms, contributing to the understanding of Ayurvedic therapies in managing Gridhrasi (Sciatica). The findings could provide valuable insights into integrating these herbs as potential treatment options for sciatica in clinical settings.
This study is crucial for advancing knowledge in Ayurvedic pain management and could have significant implications for treating sciatica with natural remedies.
|