| CTRI Number |
CTRI/2025/02/080426 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical trial to study the efficacy of two drugs Sankhapushpi and Jatamansi powder to treat patients with Anxiety Disorder. |
|
Scientific Title of Study
|
Comparative clinical study on efficacy of Sankhapushpi and Jatamansi churna in Chittodvega with special reference to Generalized Anxiety Disorder. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jimima Aktar |
| Designation |
PG Scholar |
| Affiliation |
Govt Ayurvedic college and Hospital Ghy 14 |
| Address |
Dept of Sanskrit Samhita and Siddhanta
Govt Ayurvedic college and Hospital Jalukbari Guwahati
Kamrup
ASSAM
781014
India |
| Phone |
8011067082 |
| Fax |
|
| Email |
aktarjimima@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kanika Goswami |
| Designation |
Assistant professor and Guide |
| Affiliation |
Govt Ayurvedic college and Hospital Ghy 14 |
| Address |
Dept of Sanskrit Samhita and Siddhanta
Govt Ayurvedic college and Hospital Jalukbari Guwahati
Kamrup
ASSAM
781014
India |
| Phone |
9864032837 |
| Fax |
|
| Email |
dr.kanikagoswami2010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kanika Goswami |
| Designation |
Assistant professor and Guide |
| Affiliation |
Govt Ayurvedic college and Hospital Ghy 14 |
| Address |
Dept of Sanskrit Samhita and Siddhanta
Govt Ayurvedic college and Hospital Jalukbari Guwahati
ASSAM
781014
India |
| Phone |
9864032837 |
| Fax |
|
| Email |
dr.kanikagoswami2010@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Ayurvedic college and Hospital Ghy 14 |
|
|
Primary Sponsor
|
| Name |
Dr Jimima Aktar |
| Address |
Dept of Sanskrit Samhita and Siddhanta
Govt Ayurvedic college and Hospital Jalukbari Guwahati Assam |
| 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 |
| Dr Jimima Aktar |
Govt Ayurvedic college and Hospital Guwahati |
OPD and IPD of Govt Ayurvedic college and Hospital Guwahati 14
Kamrup
ASSAM |
8011067082
aktarjimima@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee , Govt Ayurvedic college and Hospital, Jalukbari,Guwahati 781014 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F411||Generalized anxiety disorder. Ayurveda Condition: MANOVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Jatamansi , Reference: Charak samhita/Sutrasthana Chapter 4(shadvirechanshatasritiya adhyay)/Sangyasthapan mahakashay sloka48, Bhavprakash Nihgantu/chapter 3 (Karpuradi varga)/sloka75, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -warm water ), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sankhapushpi , Reference: Charak samhita/ chikitsa sthan /chapter 1.3 (karaprachatiya rasayanpada)/31 sloka, Bhavprakash Nihgantu /Guduchyadi varga chapter 4/sloka 228 , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -warm water ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age group 18 to 50yrs both male and female having anxiety of minimum 6 months duration fulfilling the diagnostic criteria DSM4/DSM5 or atleast 14 on the Hamilton anxiety rating scale. |
|
| ExclusionCriteria |
| Details |
1.Patient below 18 yrs and above 50 yrs.
2.Patient with major Psychiatric illness like Schizophrenia, Depressive psychosis, Epilepsy etc.
3.Patient like Lactating mothers, Pregnant women, medical condition like Hypothyroidism etc.
4.Patients with acute illness like CVA,CCF,MI etc. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Sankhapushpi and Jatamansi churna in Generalized anxiety disorder(Chittodvega). |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment will be done according to improvement in the anxiety rating scale. |
15,30,45 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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
22/02/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 is a randomized, parallel comparative clinical study on efficacy of Sankhapushpi and Jatamansi churna for the management of Generalized anxiety disorder.Total 60 number of patients divided in two groups and each group will be given 3 gms of powder twice daily orally and both drugs efficacy will be compared . Assessment will be done in every 15,30,45th day based on symptoms in anxiety rating scale.This study conducted as a mandatory Post graduation thesis work. |