| CTRI Number |
CTRI/2025/10/095621 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
05/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see and compare effectiveness of Ekavimshatika Guggulu and Vishwadi Guggulu with Agnikarma in management of Gridhrasi |
|
Scientific Title of Study
|
An open randomized comparative clinical study to evaluate the effect of Ekavimshatika Guggulu and Vishwadi Guggulu with Agnikarma in management of Gridhrasi. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhavya Kiran Parikh |
| Designation |
PG Resident |
| Affiliation |
Karnataka Ayurveda Medical College |
| Address |
Kayachikitsa Department, Kayachikitsa OPD, OPD no. 4, 1st floor, KECT Towers, Hoigebail, Mangalore
Dakshina Kannada
KARNATAKA
575006
India |
| Phone |
8169644814 |
| Fax |
|
| Email |
bhavyaparikh1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Waheeda Banu |
| Designation |
Guide and HOD |
| Affiliation |
Karnataka Ayurveda Medical College |
| Address |
Kayachikitsa Department, Kayachikitsa OPD, OPD no. 4, 1st floor, KECT Towers, Hoigebail, Mangalore
Dakshina Kannada
KARNATAKA
575006
India |
| Phone |
9008137091 |
| Fax |
|
| Email |
drwaheedabanu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhavya Kiran Parikh |
| Designation |
PG Resident |
| Affiliation |
Karnataka Ayurveda Medical College |
| Address |
Kayachikitsa Department, Kayachikitsa OPD, OPD no. 4, 1st floor, KECT Towers, Hoigebail, Mangalore
Dakshina Kannada
KARNATAKA
575006
India |
| Phone |
8169644814 |
| Fax |
|
| Email |
bhavyaparikh1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kayachikitsa Department, Kayachikitsa OPD, OPD no. 4, Karnataka Ayurveda Medical College, 1st floor, KECT Towers, Hoigebail, Mangalore, Dakshina Kannada, Karnataka - 575006 |
|
|
Primary Sponsor
|
| Name |
Dr Bhavya Kiran Parikh |
| Address |
Kayachikitsa Department, Kayachikitsa OPD, OPD no. 4, 1st floor, KECT Towers, Hoigebail, Mangalore, Dakshina Kannada, Karnataka
575006 |
| 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 |
| Bhavya Kiran Parikh |
Karnataka Ayurveda Medical College |
Kayachikitsa OPD, Kayachikitsa Department, 1st floor, KECT Towers, Karnataka Ayurveda Medical College
Dakshina Kannada
KARNATAKA |
8169644814
bhavyaparikh1998@gail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Clinical Ethics Committee |
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 | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Charaka Chikitsa sthan / Adhyay 28 / Shloka 101, Procedure details: Purva karma
Informed written consent of the subject will be taken
Pradhan Karma
1. At the site of Antara-Kandara-Gulpha-Madhya , which resembles Popliteal fossa & at the level of sciatic notch, 5 to 6 bindu of Samyak Dagdha Vrana were made. 2. Half Angula, which is approximately 1cm, space between two Samyak Dagdha Vrana was maintained.
Paschat Karma
Aloe vera gel will be applied on Samyak Dagdha Vrana to get rid of instant burning sensations.)
(1) Medicine Name: Ekavimshatika Guggulu, Reference: Bhavaprakash Madhyam Khanda, Kushtha Adhyay, Shloka 68-72, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1(g), Frequency: tds, Duration: 30 Days | | 2 | Comparator Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Charaka Chikitsa sthan / Adhyay 28 / Shloka 101, Procedure details: Purva karma
Informed written consent of the subject will be taken
Pradhan Karma
1. At the site of Antara-Kandara-Gulpha-Madhya , which resembles Popliteal fossa and at the level of sciatic notch, 5 to 6 bindu of Samyak Dagdha Vrana were made.
2. Half Angula, which is approximately 1cm, space between two Samyak Dagdha Vrana was maintained.
Paschat Karma
Aloe vera gel will be applied on Samyak Dagdha Vrana to get rid of instant burning sensations.)
(1) Medicine Name: Vishwadi Guggulu, Reference: Bharat Bhaishajya Ratnakar / Chaturth bhaga / Vakaradi Guggulu Prakaran / Shloka 6692, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1(g), Frequency: tds, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Freshly detected and untrated cases of Gridhrasi vis-à-vis Sciatica
2. Treated cases already diagnosed as Gridhrasi vis-à-vis Sciatica, who had voluntarily discontinued treatment with flushout period of 7 days.
3. Subjects with signs and symptoms of Gridhrasi vis-à-vis Sciatica. |
|
| ExclusionCriteria |
| Details |
1.Subjects with history of lumbar spine fracture within past 1 year.
2. Neoplastic condition of spine.
3. Infection of spine.
4. Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate Comparative Effect Of Ekavimshatika Guggulu with Agnikarma and Vishwadi Guggulu with Agnikarma in Subjects Of Gridhrasi. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study the efficacy of Ekavimshatika Guggulu with Agnikarma in subjects of Gridhrasi.
2.To study the efficacy of Vishwadi Guggulu with Agnikarma in subjects of Gridhrasi.
3. To compare the efficacy of Ekavimshatika Guggulu with Agnikarma and Vishwadi Guggulu with Agnikarma in subjects of Gridhrasi. |
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
16/10/2025 |
| 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)
|
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 a comparative study to assess the efficacy of Ekavimshatika Guugulu with Agnikarma and Vishwadi Guggulu with Agnikarma in Gridhrasi vis-a-vis Sciatica. This study will include both male and female patients freshly diagnosed of Gridhrasi within age group of 20 to 60 years. |