| CTRI Number |
CTRI/2024/10/074898 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
04/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effect of shankpushpi ghan vati and tusli ghan vati in chittodvega |
|
Scientific Title of Study
|
Comparative clinical evaluation of shankpusphi ghan vati and tulsi ghan vati in chittodvega |
| 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 Vivek Sagar |
| Designation |
PG Scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
O.P.D. 13,14, Department of Kayachikitsa, Patanjali Ayurved hospital, Phase 1, Haridwar Road
Hardwar
UTTARANCHAL
249405
India |
| Phone |
08171810270 |
| Fax |
|
| Email |
sagarvivek297@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shubham Sadh |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
O.P.D. 13,14, Department of Kayachikitsa, Patanjali Ayurved hospital, Phase 1, Haridwar Road
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8792429267 |
| Fax |
|
| Email |
Shubhamsadh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubham Sadh |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
O.P.D. 13,14, Department of Kayachikitsa, Patanjali Ayurved hospital, Phase 1, Haridwar Road
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8792429267 |
| Fax |
|
| Email |
Shubhamsadh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar, Uttarakhand, India 249405 |
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Patanjali yogpeeth phase 1, Haridwar road, Haridwar, Uttarakhand, India 249405 |
| Type of Sponsor |
Private medical college |
|
|
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 Vivek Sagar |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
O.P.D. 13,14, DEepartment of Kayachikitsa, Patanjali Ayurved hospital, Phase 1, Haridwar Road
Hardwar
UTTARANCHAL |
08171810270
sagarvivek297@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe, Patanjali Ayurved College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Chittodvega (Exam Stress)in Undergraduate students age between 18-25 years (both gender) |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Tulsi Ghan vati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: - | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Shankpushpi ghan vati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals between the age group of 18-30 years will be selected of either sex.
2. Individuals having classical sign and symptoms of Chittodvega.
3. Irrespective of gender and socioeconomic status.
4. Those students who are ready to sign the informed consent form. |
|
| ExclusionCriteria |
| Details |
1. Individuals taking any Antipsychotic drugs, Antidepressant drugs.
2. Individuals having serious diseases such as hepatic disease, cardiac disease, renal disease, pulmonary disease, history of thyroid, uncontrolled hypertension and diabetes mellitus, other endocrine disorders will be excluded.
3. Pregnant and lactating women will be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective parameters
1. ShirashShoonyta (mind going blank)
2. Chakshushorakulta (unsteady eyes)
3. Ucchawasasyadhikyam (Dyspnoea)
4. Hridgraha (Chest tightness)
5. Dhayana (Unrealistic Apprehension)
6. Ayasa (Easily become atigue)
7. Sammoha (Illusion)
8. Udvega(Palpitation)
9. Unmattchittatvam (Inability to concentrate)
10. Anannabhilasa (Anorexia)
11. Avipaka (Impaired digestion) |
0 days, 3 weeks, 7 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.The result of the treatment will be evaluation as to the degree of Anxiety according to Westside Anxiety Rating Scale.
2. Anxiety will be diagnosed by Hamilton Anxiety Rating Scale. |
0 days, 3 weeks, 7 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/10/2024 |
| Date of Study Completion (India) |
28/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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 a comparative clinical evaluation of Shankpushpi ghan vati and Tulsi ghan vati in Chittodvega (Exam stress). This will be conducted on 60 randomly selected individuals from OPD of Kayachikitsa Department of Patanjali Bharitiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar. Patients will be divided into two groups- 30 patients will be administered tarpan with Shankpushpi ghan vati and 30 patients will be administered with Tusli ghan vati. First follow up will be taken after 15 days of the administration of drug and second follow up will be taken after completion of exam. Assessment will be done on the basis of subjective and objective parameters as discussed earlier. |