| CTRI Number |
CTRI/2026/04/107808 [Registered on: 07/04/2026] Trial Registered Prospectively |
| Last Modified On: |
02/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study on Chandravaleha in Kaphaja unmada (Depressive disorder) |
|
Scientific Title of Study
|
An exploratory clinical study to evaluate the efficacy of Chandravaleha in the management of Kaphaja Unmada (Depressive disorder) |
| 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 Manish Kumar Verma |
| Designation |
MD Scholar |
| Affiliation |
PGIA Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
| Address |
PG Department Of Kaya Chikitsa PGIA Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9461948933 |
| Fax |
|
| Email |
mverma28797@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Brahmanand Sharma |
| Designation |
Associate Professor |
| Affiliation |
PGIA Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
| Address |
PG Department Of Kaya Chikitsa PGIA Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9460318138 |
| Fax |
|
| Email |
bkmudgal9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manish Kumar Verma |
| Designation |
MD Scholar |
| Affiliation |
PGIA Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
| Address |
PG Department Of Kaya Chikitsa PGIA Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
09461948933 |
| Fax |
|
| Email |
mverma28797@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Jodhpur 342037 (Rajasthan) |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurveda Jodhpur |
| Address |
Post Graduate Institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Jodhpur 342037 (Rajasthan) |
| 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 Manish Kumar Verma |
Post Graduate Institute of Ayurved |
OPD Room Number 6 Sanjeevani Chikitsalaya Department of Kaya Chikitsa PG Department Of Kaya Chikitsa Post Graduate Institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur Rajasthan 342037
Jodhpur
RAJASTHAN |
9461948933
mverma28797@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Post Graduate Institute of Ayurved Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F331||Major depressive disorder, recurrent, moderate. Ayurveda Condition: UNMADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: CHANDRAVALEHA, Reference: YOG RATNAKAR, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subject who had moderate and severe major depressive disorder diagnose according to
Hamilton Depression Rating Scale (HDRS) and must had minimum total score of 14 and
maximum of 38 on the 17 items of HDRS (Hamilton Depression Rating Scale)
Patients with classical signs and symptoms of Kaphaja Unmada.
Patients between the age group of 20 Years–60Years.
Patients of either gender.
Patients will be chosen irrespective of socioeconomic status.
Subject willing to follow the procedures as per the study protocol and voluntarily signed and
informed consent form. |
|
| ExclusionCriteria |
| Details |
Patients with other psychiatric disorders like schizophrenia, bipolar mood disorders and
substance abuse.
• Patients with other systemic disorders like uncontrolled diabetes mellitus.
• Intracranial infections such as Meningitis.
• Congenital defects – diffuse sclerosis, cerebral agenesis etc.
• Patients of other Nija unmada (Doshaja – Vata, Pitta and Sannipataja) and Bhutonmad.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the effect of Chandravaleha in the management of Kaphaja
Unmada |
45 days after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Hamilton Depression Rating Scale (HDRS) |
45 days after treatment |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
14/04/2026 |
| 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="0"
Months="1"
Days="15" |
|
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
|
This study is single arm, an open label trial, with single group of 30 patients to assess the efficacy of Chandravaleha in the management of Kaphaja Unmada. The primary objective of the study is reducing subjective criteria HDRS score. drug will be administered with milk before meal in the dosage of 6gm twice a day. Total duration of the treatment is 45 days followed up once in a week regularly. Study type- Interventional exploratory (clinical study) Allocation - Single arm Masking - Open label Timing - Prospective Total study period - 45 days |