| CTRI Number |
CTRI/2026/03/105886 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
07/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
effect of Bilvamuladi niruha basti and suryaprabha vati in musculoskeletal pain |
|
Scientific Title of Study
|
A COMPARATIVE CLINICALEVALUATION ON THE EFFECT OF BILVAMULADI NIRUHA BASTI AND SURYAPRABHA VATI IN VATIKA SHOOLA WITH SPECIAL REFERENCE TO MUSCULOSKELETAL PAIN |
| Trial Acronym |
AYURVEDA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nidhi Pandey |
| Designation |
M.D. Scholar |
| Affiliation |
Goverment P.G.Ayurvedic college and hospital ,varanasi |
| Address |
P.G. Department of Panchakarma
Government P.G.Ayurvedic college and Hospital ,Varanasi
uttar pradesh
221002
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
6307295598 |
| Fax |
|
| Email |
nidhi.pandey231996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta Mishra |
| Designation |
Assistant Professor |
| Affiliation |
Goverment P.G.Ayurvedic college and hospital ,varanasi |
| Address |
Department of Kayachikitsa and Panchakarma ,Government P.G.Ayurvedic college and Hospital, Varanasi
Government P.G.Ayurvedic college and Hospital ,Varanasi
uttar pradesh
221002
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9721217773 |
| Fax |
|
| Email |
drshwetamishraaiia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nidhi Pandey |
| Designation |
M.D. Scholar |
| Affiliation |
Goverment P.G.Ayurvedic college and hospital ,varanasi |
| Address |
P.G. Department of Panchakarma
Government P.G.Ayurvedic college and Hospital ,Varanasi
uttar pradesh
221002
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
6307295598 |
| Fax |
|
| Email |
nidhi.pandey231996@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Government P.G.Ayurvedic college and hospital,Varansi |
| Address |
Department of Panchakarma, Government P.G.Ayurvedic college and Hospital ,Varansi |
| 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 Nidhi Pandey |
Government Ayurvedic College And Hospital |
OPD No 8 and 11 and IPD of Kayachikitsa and Panchkarma Government PG Ayurvedic College and Hospital Varanasi Uttar Pradesh
Varanasi
UTTAR PRADESH |
6307295598
nidhi.pandey231996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, Government Ayurveda College and Hospital Varanasi U.P., Mahayogi Guru Gorakhnath AYUSH University, Gorakhpur U.P |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M959||Acquired deformity of musculoskeletal system, unspecified. Ayurveda Condition: VATASULAVYAPAT, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | BASTI | (Procedure Reference: YOGA RATNAKAR UTTARARDHA SHO ROGAADHIKAR 29AND 61, Procedure details: SCHEDULE (KALA BASTI)
Basti will be administered as per the concept of Charaka for kala basti
Niruha basti Total amount 650-960 ml(according to bala )
Anuvasana BastiTila taila 50 ml
Duration:16 Days
Follow Up There will be 2 follow ups at the gap of 7 day
F1 at 23 day
F2 at 30day
)
| | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: SURYAPRABHA VATI, Reference: YOGA RATNAKAR UTTARARDHA SHOOLA ROGAADHIKAR 29 AND 74, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 16 Days, anupAna/sahapAna: No, Additional Information: SURYAPRABHA VATI
Drugs Shunthi pippali MarichaPippalimoola VachaChitrakamoolaShuddh
HinguJeeraka dwaya Vatsnabha
Bhawana Dravya: Jambiri NimbuArdraka swarasa
Dose250TO500mg BD (according to bala)
Time of administration Oral
Duration 16 Days
Follow Up will be 2 follow up at the gap of 7 days
F1 at 23 day
F2 at 30 day | | 3 | Comparator Arm | Procedure | - | BASTI | (Procedure Reference: YOGA RATANKAR UTTARARDHA SHOOLA ROGAADHIKAR 29, Procedure details: BILVAMULADI NIRUHA BASTI and SURYAPRABHA VATI
BILVAMULADI NIRUHA BASTI
SCHEDULE (KALA BASTI)
Basti will be administered as per the concept
of Charaka for kala basti
Niruha Basti Total amount 650to960 ml
(according to bala)
Anuvasana Basti Tila taila 50 ml
Duration 16 days
Follow up There will be 2 follow ups at the
gap of 7 days
F1 at 23 day
F2 at 30 day
SURYAPRABHA VATI
Dose:250-500 ml (according to bala)
Time of administration Morning &Evening
Mode of administration Oral
Duration 16days
Follow up There will be 2 follow up at the gap
of 7 days
F1 at23day
F2at 30 day
)
(1) Medicine Name: SURYAPRABHA VATI , Reference: YOGA RATANKAR UTTARARDHA SHOOLAADHIKAR 29, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Duration: 16 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients are selected irrespective of sex, occupation, caste etc.,Patient between age group of
16years to 70 years , Patient having symptoms of (musculoskeletal disorder) shool, patients yogya
of basti,patient has musculoskeletal pain but cause is not long term or chronic,patients who have
history of less than one year. |
|
| ExclusionCriteria |
| Details |
Patient below age of 16years and above 70years, Pregnant women, lactating mothers,Patients
present with metabolic disorders,SPDs (sensory processing disorder), Patients present with
complaint of piles or fistula,patients who have tuberculosis of vertebral bodies, benign or
malignant condition,patients who have any chronic disease,any surgical emergency,patients who
have uncontrolled diabetes,hypertension.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in pain |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| lifestyle modification, |
30 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)
|
20/03/2026 |
| 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="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
|
This study is randomized ,parallel group study trial comparing the efficacy of Bilvamuladi Nirhua basti and suryaprabha vati in vatika shoola with special reference to musculoskeletal pain . Patients will be selected randomly from OPD and IPD of department of Kayachikitsa and Panchkarma , Goverment P.G. Ayurvedic college and Hospital, Varanasi. A total no. of 60 patients will be studied under 3 group having in 20 patients in each group. Group A : IN this group 20 patients will be treated with bilvamuladi nirhua basti for 16 days Group B: In this group 20 patients will be treated with suryaprabha vati orally for 16 days Group C:In this group 20 patients will be treated with bilvamuladi basti and suryaprabha vati both for 16 days TWO FOLLOW UPS WILL BE DONE -First on 23 day and 2 follow up on 30 day. |