| CTRI Number |
CTRI/2025/07/090600 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/06/2025 |
| 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
|
A Clinical Study on the Management of Gridhrasi with Rasnasaptak Kwath and Nirgundi Ghanvati |
|
Scientific Title of Study
|
A Conceptual Study of Nanatmaja Vikara wsr to Gridhrasi and its Management by Rasnasaptak Kwath and Nirgundi Ghan Vati |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SONAM YADAV |
| Designation |
P.G. Scholar |
| Affiliation |
Mansarovar Ayurvedic Medical College, Hospital and Research Centre |
| Address |
Department of Samhita Siddhanta, Third Floor, Room Number 301
Mansarovar Ayurvedic Medical College, Hospital and Research Centre
Hinotiya Alam, Kolar Road, Bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
7974400649 |
| Fax |
|
| Email |
dr.sonam649@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Krishna Kumar Tiwari |
| Designation |
Associate Professor |
| Affiliation |
Mansarovar Ayurvedic Medical College, Hospital and Research Centre |
| Address |
Department of Samhita Siddhanta, Third Floor, Room Number 301
Mansarovar Ayurvedic Medical College, Hospital and Research Centre
Hinotiya Alam, Kolar Road, Bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
9424591086 |
| Fax |
|
| Email |
drkrishna_tiwari@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
SONAM YADAV |
| Designation |
P.G. Scholar |
| Affiliation |
Mansarovar Ayurvedic Medical College, Hospital and Research Centre |
| Address |
Department of Samhita Siddhanta, Third Floor, Room Number 301
Mansarovar Ayurvedic Medical College, Hospital and Research Centre
Hinotiya Alam, Kolar Road, Bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
7974400649 |
| Fax |
|
| Email |
dr.sonam649@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mansarovar Ayurvedic Medical College, Hospital and Research Centre, Hinotia Alam, Kolar Road, Bhopal, Madhya Pradesh, 462042, India |
|
|
Primary Sponsor
|
| Name |
Mansarovar Ayurvedic Medical College, Hospital and Research Centre, Bhopal |
| Address |
Department of Samhita Siddhanta, Third Floor, Room Number 301
Mansarovar Ayurvedic Medical College, Hospital and Research Centre, Hinotia Alam, Kolar Road, Bhopal |
| 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 Sonam Yadav |
Mansarovar Ayurvedic Medical College, Hospital and Research Centre |
Department of Samhita Siddhanta, Third Floor, Room Number 301, Mansarovar Ayurvedic Medical College, Hinotia Alam, Kolar Road
Bhopal
MADHYA PRADESH |
7974400649
dr.sonam649@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Mansarovar Ayurvedic Medical College and Research Centre bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M512||Other thoracic, thoracolumbar andlumbosacral intervertebral disc displacement. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nirgundighan Vati, Reference: Dhanvantri Nighantu, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: sukhoshan jal), Additional Information: No | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rasnasaptak Kwath, Reference: Bhavprakash, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: No |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient having classical signs and symptoms of Gridhrasi that is Ruka, Toda, Stambha, Spandan in the Sphika, Kati, Uru, Janu, Jangha and Pada.
2. Patient having classical sign and symptoms of Sciatica according to modern text that is tenderness along the course of Sciatic nerve, positive SLR test. |
|
| ExclusionCriteria |
| Details |
1. Major traumatic injury.
2. Severe radiological changes requiring surgical intervention.
3. Patient suffering from any chronic debiliting disease like tuberculosis, Diabetes Mellitus, Cancer Spine.
4. Patient suffering from autoimmune disease, Rheumatic Arthritis, Alkalosis. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| After the completion of the patients medication period that is 60 days the changes in the symptoms of Gridhrasi will be evaluated and the results of Rasna Saptak Kwatha and Nirgundi Ghan Vati will be compared |
60 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Based on the changes in symptoms after the end of the patients medication period of 60 days we will study the mode of action of Rasna Saptak Kwatha and Nirgundi Ghan Vati and study the relation between Nanatmaja Vikara and Gridhrasi |
60 Days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
14/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
14/07/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
In modern science, treatment of Gridhrasi (sciatica) is not very satisfactory its includes analgesics and few surgical procedures which is often associated with adverse effect.Sciatica (known as Gridhrasi in Ayurveda) is a common and painful condition, but current modern treatments like painkillers and surgery often do not provide long-term relief and may cause side effects. According to studies, the yearly incidence is between 1% to 5%, and up to 40% of people may experience it at some point in their life. It is seen more often in non-working individuals (7.9%) than in those who are working (3.8%).
Due to the limitations of existing treatments, there is a strong need to explore safer and more effective alternatives. This study aims to evaluate the effect of an Ayurvedic formulation through a clinical drug trial. The goal is to find better treatment options with fewer side effects and improved outcomes for patients suffering from Gridhrasi. |