| CTRI Number |
CTRI/2026/02/103197 [Registered on: 06/02/2026] Trial Registered Prospectively |
| Last Modified On: |
27/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Study on the Benefits of Polyherbal Decoction Treatment for Neck and Back Pain Due to Nerve Problems |
|
Scientific Title of Study
|
Evaluation of Efficacy of Polyherbal Formulation in Khalli (Cevico-Lumbar Radiculopathy)- A Single Arm Clinical Study |
| 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 Sagar Bharat Kale |
| Designation |
PG Scholar Kayachikitsa |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre, Pimpri, Pune |
| Address |
Department of Kayachikitsa, Dr. D. Y. Patil College of Ayurved and Research Centre, Pimpri, Pune
MAHARASHTRA
Pune
MAHARASHTRA
411018
India |
| Phone |
7588104498 |
| Fax |
|
| Email |
sagarbkale100@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D G Dipankar |
| Designation |
HOD and Professor Kayachikitsa |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre, Pimpri, Pune |
| Address |
Department of Kayachikitsa, Dr. D. Y. Patil College of Ayurved and Research Centre, Pimpri, Pune
MAHARASHTRA
Pune
MAHARASHTRA
411018
India |
| Phone |
9822279321 |
| Fax |
|
| Email |
digambar.dipankar@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sagar Bharat Kale |
| Designation |
PG Scholar Kayachikitsa |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre, Pimpri, Pune |
| Address |
Department of Kayachikitsa, Dr. D. Y. Patil College of Ayurved and Research Centre, Pimpri, Pune
MAHARASHTRA
Pune
MAHARASHTRA
411018
India |
| Phone |
7588104498 |
| Fax |
|
| Email |
sagarbkale100@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sagar Bharat Kale |
| Address |
Department of Kayachikitsa, Dr. D. Y. Patil College of Ayurved and Research Centre, Pimpri, Pune 411018, Maharashtra, India
Pune
MAHARASHTRA |
| 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 Sagar Bharat Kale |
Dr. D. Y. Patil College of Ayurved and Research Centre, Pimpri, Pune |
OPD No 5, IPD Of Dept of Kayachikitsa, Dr.D.Y.Patil College of Ayurved and Research Centre, Pimpri, Pune
Pune
MAHARASHTRA |
7588104498
sagarbkale100@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR.DYPCA&RC INSTITUTIONAL ETHICS COMMITTEE PIMPRI PUNE 411018 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M541||Radiculopathy. Ayurveda Condition: KHALLI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Polyherbal Formulation , Reference: NA, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 80(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling the criteria for diagnosis of Khalli such as Shoola (pain) in Paad (Legs), Jangha (Calves), Uru (Thighs) and Karmula (Wrist). |
|
| ExclusionCriteria |
| Details |
Patients with known case of Musculoskeletal disorders like
Amavata (Rheumatoid arthritis), Vata-rakta (Gout).
Patients with known case of Neurological disorders like Muscular
dystrophy, Myasthenia gravis.
Patients with a history of Tuberculosis, Malignancy, Trauma.
Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in symptom Shoola (pain) of Khalli after the treatment.
|
28 days study with follow ups on 14th and 28th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in VAS scale score and Pain Detect Questionnaier Score.
Improvement in Spurling Test and SLR Test. |
28 days study with follow ups on 14th and 28th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
09/03/2026 |
| 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="1"
Months="6"
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 AIMS TO STUDY THE EFFICACY OF POLYHERBAL FORMULATION ON 30 PATIENTS SUFFERING FROM KHALLI (CERVICO-LUMBAR RADICULOPATHY) .
40 ML KWATH WILL BE ADMINISTERED TWICE A DAY FOR THE DURATION OF 28DAYS AND WITH 14TH AND 28TH DAY AS FOLLOW UP DAYS.
FINAL CONCLUSION WILL BE DRAWN ON THE BASIS OF STATISTICAL ANALYSIS |