| CTRI Number |
CTRI/2025/06/088756 [Registered on: 12/06/2025] Trial Registered Prospectively |
| Last Modified On: |
05/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical trial to study the effect of Krishna Churna with Erand tail pan in patients of Gridhrasi |
|
Scientific Title of Study
|
A randomized placebo controlled clinical Trial to study the efficacy of krishna churna with erand tail pan in the management of 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 |
Shraddha Vijay Sonar |
| Designation |
PG scholar |
| Affiliation |
Siddhakala Ayurved Mahavidyalaya |
| Address |
OPD number 1 kaychikitsa department Siddhakala Ayurved Mahavidyalaya pimparne road Sangmner Ahmadnagar Maharashtra
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9545806406 |
| Fax |
|
| Email |
Shraddhasonar2898@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Sandeep Gorakh Mane |
| Designation |
Professor kaychikitsa department |
| Affiliation |
Siddhakala Ayurved Mahavidyalaya Sangamner |
| Address |
Siddhakala Ayurved Mahavidyalaya pimparne road Sangamner Ahmadnagar Maharashtra India
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9730657903 |
| Fax |
|
| Email |
drsgmane@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Sandeep Gorakh Mane |
| Designation |
Professor kaychikitsa department |
| Affiliation |
Siddhakala Ayurved Mahavidyalaya pimparne road Sangamner |
| Address |
Siddhakala Ayurved Mahavidyalaya pimparne road Sangamner Ahmadnagar Maharashtra India
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9730657903 |
| Fax |
|
| Email |
drsgmane@gmail.com |
|
|
Source of Monetary or Material Support
|
| Siddhakala Ayurved Mahavidyalaya pimparne road Sangamner 422605 Ahmadnagar Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Shraddha Vijay Sonar |
| Address |
Sidhakala Ayurved mahavidyalaya Sangamner Maharashtra 422605 |
| Type of Sponsor |
Other [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 Shraddha Vijay Sonar |
Siddhakala Ayurved Mahavidyalaya Sangamner pimparne road Ahmadnagar Maharashtra |
Ground floor OPD no. 1 kaychikitsa department Siddhakala Ayurved Mahavidyalaya Sangamner Ahmadnagar Maharashtra
Ahmadnagar
MAHARASHTRA |
9545806406
shraddhasonar2898@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Board of Ayurveda Research and Statistics Committee of Siddhakala Ayurved Mahavidyalaya Sangamner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G00-G99||Diseases of the nervous system. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Placebo | Placebo (maize starch)125mg capsule, route -oral , dosage form- 125mg capsule, frequency - BD, duration -30 days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Krishna churna , Reference: Chakradatta , Route: Oral, Dosage Form: Churna/ Powder, Dose: 125(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -erand tail ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Symptoms of patients should be as per the Gridhrasi mentioned in samhita. |
|
| ExclusionCriteria |
| Details |
Patients having age below 18 years and above 70 years.
Patients having surgical history of high risk.
Pregnant and lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study in detail the efficacy of krishna churna with erand tail pan in management of gridhrasi with special reference to scitica. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study the Ayurvedic and Modern aspect of etiopathogenesis of Gridhrasi with special reference to Sciatica.
2. To study the properties and efficacy of Krishna churna with Erand tail as per mentioned in Ayurveda Samhita.
3. To assess the outcome of both the groups I.e A and B |
30 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
20/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/06/2025 |
| 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 Yet Recruiting |
| 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
|
It is Randomized Control Clinical trial 80 patients taken for study 40 patients in each group Studying efficacy of Krishna Churna with Erand Tail Pan for 30 days in management of Gridhrasi with special reference to Sciatica |