| CTRI Number |
CTRI/2025/08/093045 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/05/2026 |
| 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
|
Evaluate the Comparative effect of Parijata (Nyctanthes arbor-tristis)and Shinshapa (Dalbergia sisoo) in treatment of Gridhrasi(Sciatica) |
|
Scientific Title of Study
|
A COMPARATIVE STUDY OF PARIJATA (Nyctanthes arbor-tristis Linn.) AND SHINSHAPA (Dalbergia Sissoo Roxb.) W.S.R. TO GRIDHRASI ( 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 Pallavi kodle |
| Designation |
M.D. Scholar, Dravyaguna |
| Affiliation |
Pt. Khushilal Sharma Ayu. College Bhopal M.P. |
| Address |
Room No.226, PG Department Of Dravyaguna, Pt. Khushilal Sharma
Government Autonomus Ayurveda College and Institute, Science
Hills Behind MANIT, Bhopal, Madhya Pradesh, India, 462003
Room No.32 Pt. Khushilal Sharma
Government Ayurveda Girls Hostel, Science
Hills Behind MANIT, Nehrunagar, Bhopal, Madhya Pradesh, India, 462003
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9429151899 |
| Fax |
|
| Email |
ppallavikodle@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K C Garg |
| Designation |
HOD and Professor Incharge |
| Affiliation |
Pt. Khushilal Sharma Ayu. College Bhopal M.P. |
| Address |
Room No.226, PG Department Of Dravyaguna, Pt. Khushilal Sharma Govrnment Ayurveda College,Bhopal, Madhya Pradesh
41,Tirupati nagar, Neelbad, Bhopal. (pin - 46578), MP.
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8821903928 |
| Fax |
|
| Email |
gargkamalcharan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K C Garg |
| Designation |
HOD and Professor Incharge |
| Affiliation |
Pt. Khushilal Sharma Ayu. College Bhopal M.P. |
| Address |
Room No.226, PG Department Of Dravyaguna, Pt. Khushilal Sharma Govrnment Ayurveda College,Bhopal, Madhya Pradesh
41,Tirupati nagar, Neelbad, Bhopal. (pin - 46578), MP.
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8821903928 |
| Fax |
|
| Email |
gargkamalcharan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. Khushilal Sharma Ayu. College and Institute, Bhopal |
|
|
Primary Sponsor
|
| Name |
Pt. Khushilal Sharma Ayu. College Bhopal, M.P. |
| Address |
Pt. Khushilal Sharma Ayu. College and Institute,Science Hills Behind Manit, Bhopal, Madhya Pradesh, India 462003 |
| Type of Sponsor |
Other [State Govt. Ayurveda College and Institute] |
|
|
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 Pallavi kodle |
Pt. Khushilal Sharma Government Autonomus Ayurveda College and institute, Bhopal, M.P. |
OPD No.1,Department Of kayachikitsa, Pt. Khushilal Sharma
Government Autonomus Ayurveda College and Institute, Science
Hills Behind MANIT, Bhopal, Madhya Pradesh, India, 462003
Room No.32 Pt. Khushilal Sharma
Government Ayurveda Girls Hostel, Science
Hills Behind MANIT, Nehrunagar, Bhopal, Madhya Pradesh, India, 462003
Bhopal
MADHYA PRADESH |
09429151899
ppallavikodle@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee, Pt. Khushilal Sharma Ayu. College and Institute, Bhopal |
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: Parijata (Nyctanthes arbor-tristis, Reference: Bhavaprakash Chikitsa khanda 24/142, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: SHINSHAPA (Dalbergia Sissoo Roxb.), Reference: Vangasen sahita Vaatvyadhi adhikar 608-609, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age between 21 Years to 60 Years.
2. Duration of illness upto 2 years.
3. Radiating Pain Starting from the gluteal region towards the foot (especially big toe).
4. Non involvement of urinary bladder and rectum.
5. Sever pain on squatting.
6. Patients fulfilling the diagnostic criteria.
7.Positive straight leg raising test.
8.Patients willing to sign the consent for participation in study.
|
|
| ExclusionCriteria |
| Details |
1. Age below 21 Years above 60 Years.
2. Patients having spinal tomour, TB, malignant disease of the pelvis, fracture of spine, congenital or acquired skeletal deformity.
3. Duration of disease more than 2 years.
4. Recent traumatic condition of spine leading to paralysis.
5.Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in Subjective Criteria –
1. Ruk (Pain)
2. Stambh (Stiffness)
3. Spandana (Pulsation)
4. Toda (Pricking Pain)
|
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/09/2025 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim of the Study: To provide a safe and simple herbal drug for patients with Gridhrasi (Sciatica) and to evaluate the comparative efficacy of the herbal drugs Parijata (Nyctanthes arbor-tristis) and Shinshapa (Dalbergia sissoo). Participants: Forty participants fulfilling the inclusion criteria will be recruited from the Outpatient Department (OPD) of the Department of Kayachikitsa at Pt. Khushilal Sharma Govt. (Auto.) Ayurveda College and Institute Bhopal. The study protocol will be approved by the Institutional Ethics Committee, and informed consent will be obtained from all participants. Study Groups: The 40 participants will be randomly divided into two groups of 20 each. * Group A (Parijata Group): Participants in this group will receive the herbal drug Parijata. * Group B (Shinshapa Group): Participants in this group will receive the herbal drug Shinshapa. Assessment Criteria: Efficacy will be assessed by comparing the following subjective and objective parameters before and after the treatment period. I. Subjective Criteria: * Ruk (Pain) * Stambh (Stiffness) * Spandana (Pulsation) * Toda (Pricking Pain) II. Objective Criteria (CCRAS): * Straight Leg Raising Test: The angle of elevation will be measured in degrees. * Ankle Jerk: Assessed for presence and intensity. * Knee Jerk: Assessed for presence and intensity. * Plantar Reflex: Assessed for presence and intensity. |