| CTRI Number |
CTRI/2025/02/080608 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of draksharishta as a physical health promoter in treated cases of pulmonary tuberculosis |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the effect of draksharishta as a physical health promoter in treated cases of rajayakshma vis-a-vis pulmonary tuberculosis
|
| 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 Shivani Parganiha |
| Designation |
PG Scholar |
| Affiliation |
JSS Ayurveda medical college and hospital |
| Address |
Department of PG Studies in Swasthavritta, JSS Ayurveda medical college and hospital, Lalithadripura road, Mysuru
Mysore KARNATAKA 570028 India |
| Phone |
9479053639 |
| Fax |
|
| Email |
shivani31par@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shalini S |
| Designation |
Reader |
| Affiliation |
JSS Ayurveda medical college and hospital |
| Address |
Department of PG Studies in Swasthavritta, JSS Ayurveda medical college and hospital, Lalithadripura road, Mysuru
Mysore KARNATAKA 570028 India |
| Phone |
9886600552 |
| Fax |
|
| Email |
shalini6771@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shalini S |
| Designation |
Reader |
| Affiliation |
JSS Ayurveda medical college and hospital |
| Address |
Department of PG Studies in Swasthavritta, JSS Ayurveda medical college and hospital, Lalithadripura road, Mysuru
KARNATAKA 570028 India |
| Phone |
9886600552 |
| Fax |
|
| Email |
shalini6771@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS Ayurveda medical college and hospital, Lalithadripura Road, Mysuru, India 570028 |
| PK TB and CD Hospital, Kumbarakoppal, Gokulam, Mysuru, India 570016 |
|
|
Primary Sponsor
|
| Name |
Dr Shivani Parganiha |
| Address |
Department of PG Studies in Swasthavritta, JSS Ayurveda medical college and hospital, Lalithadripura road, Mysuru |
| 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 Shivani Parganiha |
JSS Ayurveda medical college and hospital |
Department of PG studies in Swasthavritta, OPD 12, JSS Ayurveda medical college and hospital, Lalithadripura road, Mysuru Mysore KARNATAKA |
9479053639
shivani31par@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS Ayurveda medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:A150||Tuberculosis of lung. Ayurveda Condition: RAJAYAKSHMA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Draksharishta, Reference: Bhaishajya Kalpana, Route: Oral, Dosage Form: Arishta, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -jala), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Wait list group | |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects between the age of 18-45 years irrespective of gender and socio-economic status.
2. PTB subjects after completion of DOTS treatment protocol.
3. Subjects willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Pregnant women and lactating mother with PTB.
2. PTB subjects who are under treatment.
3. PTB subjects with diabetes mellitus.
4. Extrapulmonary TB and Surgical PTB cases
5. HIV and PTB coinfection
6. PTB subjects infected with STDs. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in physical health and less symptoms compared to control group |
45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Maintanence of imporved in physical health and less symptoms compared to control group |
90th day |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
03/03/2025 |
| 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 Applicable |
| 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
|
NEED FOR STUDY Swasthasya Swasthyarakshanam, Aturasya Vikaraprashamanam, is the main aim of Ayurveda which describe the importance of maintaining and promoting the health in addition to treating illness. Diseases are destroyers of health and well being, which is infectious, communicable and health deteriorating are explained in Ayurveda. Rajayakshma is one of them which is considered aupsargika vyadhi (communicable disease) and also is asadhya as it is associated with loss of strength and muscle wasting due to kshaya. Sahasa, vega sandarana, kshaya, vishamashana, are the four causes of rajayakshma and shows its symptoms like pinasa, shwasa, kasa, aruchi, vitsamsrana, chardi all leads to kshaya or shosha of the body. Rajayakshma can be correlated with pulmonary tuberculosis in modern science, in which the rasadi dhatus gets diminished, leading to decreased strength and activity levels, it is also known as rogarat, the king of diseases, governing all other illnesses. In 2023, incidence of TB increased slightly to 27.8 lakh from the previous year’s estimation of 27.4 lakh. The disease itself and DOTS treatment can diminish the physical health of the patient and is a challenging task for the physician to revive undernourished health into normalcy and also to prevent the recurrency of the infection due to impaired immunity. Even the government provides monthly support of Rs.500 to nearly 1crore beneficiaries for undernourished TB patients estimated 7.44 lakh as reported in 2022. In Ayurveda, to treat the undernourishment in PTB infected person, numerous methods and medications has been indicated. One such formulation explained in bhaishajya ratnavali is draksharishta as balya. Hence, this is a trial taken to see the effect of draksharishta in treated cases of PTB to improve and promote the physical health status particularly focusing on weight and physical attributes.
AIMS & OBJECTIVE OF THE STUDY 1. To evaluate the effect of draksharishta as physical health promoter in treated cases of PTB 2. To evaluate the physical health of the wait list subjects in treated cases of PTB. 3. To compare the efficacy of draksharishta and wait list subjects in treated cases of PTB
SAMPLE SIZE: 30 subjects diagnosed with PTB (irrespective of gender) and completed Treatment protocol will be taken into 2 groups based on randomized sampling method. Group A-15 subjects (wait list group) Group B-15 subjects (interventional group)
PLAN OF TREATMENT: GROUP A: Sample Size- 15 subjects(wait list group) GROUP B: Sample size- 15 subjects(interventional group) Subjects after fulfilling the criteria and after taking informed consent. Draksharishta will be procured from GMP certified pharmacy and will be given in Dose-25ml BD after food with equal quantity of water for 45days.
ASSESSMENT CRITERIA: Subjects will be assessed before and at the end of the month on 0th day, 15th day, 30th day, 45th day and follow up on 90th day by using following scales
OBJECTIVE: 1. Weight 2. BMI 3. Mid Arm circumference 4. Skin fold thickness |