| CTRI Number |
CTRI/2025/07/090916 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
a clinical trial to assess effect of Tilayasthi madhu kshir Gandusha Dharan in the management of dantaharsha |
|
Scientific Title of Study
|
Randomised controlled clinical trial to assess the effect of Tilayasthi madhu kshir Gandusha Dharan in the management of dantaharsha W.S.R to dentine hypersensitivity |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Geeta Digambar kale |
| Designation |
Pre MS shalakyatantra |
| Affiliation |
SST ayurved college sangamner |
| Address |
sangam sevabhavi trust ayurved college sangamner,dept shalakyatantra
2nd floor
room no 3
sangam sevabhavi trust ayurved college shalakyatantra opd
ground floor
3no opd
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9022108473 |
| Fax |
|
| Email |
geetakale5556@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Anil Deshmukh |
| Designation |
Guide department _shalakyatantra |
| Affiliation |
SST ayurved college sangamner |
| Address |
sangam sevabhavi trust ayurved college sangamner department_shalakyatantra
2nd floor
3 no room
sangam sevabhavi trust ayurved college sangamner
dept _shakalakyatantra
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9022108473 |
| Fax |
|
| Email |
ranwaranil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Geeta Digambar kale |
| Designation |
Pre MS shalakyatantra |
| Affiliation |
SST ayurved college sangamner |
| Address |
sangam sevabhavi trust ayurved college sangamner
department_shalakyatantra
2nd floor
3rd no room
sangam sevabhavi trust ayurved college sangamner
dept _shalakyatantra
2nd floor
3rd no room
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9022108473 |
| Fax |
|
| Email |
geetakale5556@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sangam sevabhavi trust ayurved college sangamner |
|
|
Primary Sponsor
|
| Name |
Geeta Digambar kale |
| Address |
Sangam sevabhavi trust ayurved college sangamner
shalakyatantra opd
ground floor |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| Nil |
Nil |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrGeeta Digambar kale |
Sangamner |
Sangam sevabhavi trust and ayurved college sangamner
Ahmadnagar
MAHARASHTRA |
9022108473
geetakale5556@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sangam sevabhavi trust ayurved college ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:A30-A49||Other bacterial diseases. Ayurveda Condition: DANTAHARSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Tilayasthimdhu shrut kshir , Reference: madhav nidan , Route: Oral, Dosage Form: Ksheerpaka, Dose: 188(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient whose informed written consent has been taken.
2. Patients of age group between 18 to 60 years.
3. Cases of Dantaharsha diagnosed with classical features: Teeth
incapability to tolerate breeze. Teeth intolerance to Ushna (hot), Sheeta
(cold) or Amla (sour) food substances. |
|
| ExclusionCriteria |
| Details |
1. Patient is suffering from other than Dantaharsha k/c/o/ dental
caries, gingivitis, acute stomatitis are excluded.
2. Traumatic conditions of oral cavity.
3. Patient contraindicated for Gandusha karma. such as Vishaprayoga,
murchha, shosh, raktapitta, kupitaakshita, aruchi 32
4. Patients complaining pyorrhea, Infective conditions, Acute / severe
attrition reaching the pulp, Any trauma due to occlusion, Aggressive
periodontitis.
5. pregnant and lactating women are excluded |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| effect of tilayasthimdhu shrut kshir in dantaharsha |
18 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
|
| effect of tilayasthimdhu shrut kshir more effective than dashmooladi taila |
14 days |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
25/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/07/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="6" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Study to see efficacy of trial group has been been started as comparision of control group trial group _tilayasthimdhu shrut kshir control group _dashmooladi taila
|