| CTRI Number |
CTRI/2025/05/086932 [Registered on: 14/05/2025] Trial Registered Prospectively |
| Last Modified On: |
30/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Study The Analgesic Effect Of Herbal Sachet In The Patient Of Toothache. |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Analgesic Effect Of Polyherbal Formulation Sachet And Diclofenac Sachet In Dantashool W.S.R. To Toothache. |
| 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 Dipak Ajalsonde |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurveda and Research, Parul University, Vadodara, Gujarat |
| Address |
2nd floor,Department of ShalakyaTantra, Parul Institute of Ayurveda and Research, Parul University,P.O. Limda, Tal- Waghodia, Dist-Vadodara, Gujarat
Vadodara
GUJARAT
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9579731303 |
| Fax |
|
| Email |
deepak.ajalsonde@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K L Mahajan |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Ayurveda and Research, Parul University, Vadodara, Gujarat |
| Address |
2nd floor,Department of ShalakyaTantra, Parul Institute of Ayurveda and Research, Parul University,P.O. Limda, Tal- Waghodia, Dist-Vadodara, Gujarat
Vadodara
GUJARAT
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9834461296 |
| Fax |
|
| Email |
khemchandra.mahajan86270@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr K L Mahajan |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Ayurveda and Research, Parul University, Vadodara, Gujarat |
| Address |
2nd floor,Department of ShalakyaTantra, Parul Institute of Ayurveda and Research, Parul University,P.O. Limda, Tal- Waghodia, Dist-Vadodara, Gujarat
Vadodara
GUJARAT
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9834461296 |
| Fax |
|
| Email |
khemchandra.mahajan86270@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Dr Dipak Ajalsonde, Post Graduate Scholar, Department of ShalakyaTantra, Parul Institute of Ayurved and Research Parul University,Ishwarpura, P.O. Limda Vadodara Gujarat India Pincode- 391760 |
|
|
Primary Sponsor
|
| Name |
Parul Institute Of Ayurveda And Research |
| Address |
Parul Institute of Ayurveda and Research, Parul University,P.O. Limda, Tal- Waghodia, Dist-vadodara, Gujarat,India 391760 |
| 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 Dipak Ajalsonde |
KHEMDAS HOSPITAL |
OPD No: -3, Department of Shalakyatantra ,ENT OPD, Ground Floor, Ishwarpura, P.O. Limda, Tal- Waghodia, Dist-Vadodara, Gujarat India 391760
Vadodara
GUJARAT
Vadodara
GUJARAT |
9579731303
deepak.ajalsonde@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIAR-IECHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:Z764||Other boarder to healthcare facility. Ayurveda Condition: DANTAGATAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Diclofenac Sachet 50mg | Topical sachets provide short-term pain relief and should be used until a healthcare professional can address the underlying cause of the toothache. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Polyherbal Sachet, Reference: Ashtang Sanghrah Uttarsthan 22, Route: Topical, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: sos, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 1 Days, Reference: No, Route: -, Dosage Form: Churna/ Powder, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The Patients Who Are Diagnosed On The Basis Of Signs And Symptoms Of Dantshool. |
|
| ExclusionCriteria |
| Details |
Age: Below 18 years And above 60 years.
Fractured tooth.
Patients with periodontal abscess.
Patients with other diseases of oral cavity.
CHD Patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduces the severity of toothache. |
at baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Toothache Severity, Quality of Life, Changes in Sleep Quality, etc. |
at baseline. |
|
|
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)
|
01/07/2025 |
| 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
|
Toothache, known as Dantashool in Ayurveda, is a common dental condition that presents significant challenges due to its diverse causes and debilitating symptoms. Traditional management primarily utilizes pharmacological interventions, particularly non-steroidal anti-inflammatory drugs (NSAIDs) such as diclofenac, which alleviate pain through the inhibition of prostaglandin synthesis. However, concerns regarding their adverse effects, including gastrointestinal and cardiovascular risks, underscore the need for safer alternatives. This study aims to conduct a comparative clinical evaluation of the analgesic efficacy and safety of a polyherbal formulation sachet versus diclofenac sachet in managing toothache. By analyzing the effectiveness, tolerability, and adverse reactions of these two interventions, this research seeks to provide insights into the potential of polyherbal formulations as a viable alternative for pain management in dental practice. The implications of this study could enhance the quality of dental care by optimizing pain relief while minimizing risks associated with conventional NSAIDs, ultimately contributing to improved oral health outcomes for individuals suffering from toothache. |