| CTRI Number |
CTRI/2021/07/034937 [Registered on: 16/07/2021] Trial Registered Prospectively |
| Last Modified On: |
02/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the efficacy and safety of Ayurveda therapy protocol in the management of Covid-19 and its Post complications |
|
Scientific Title of Study
|
A prospective, interventional, single-arm clinical trial to evaluate the efficacy and safety of Ayurveda therapy protocol in the management of mild to moderate COVID-19 patients and its post complications |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrJHareendran Nair |
| Designation |
Managing Director and Founder |
| Affiliation |
Pankajakasthuri Herbal research Foundation |
| Address |
Department of kayachikitsa,Room No 1, Pankajakasthuri Herbal research Foundation Pankajakasthuri
Ayurveda Medical college Kattakkada Trivandrum
Thiruvananthapuram
KERALA
695572
India |
| Phone |
9447096201 |
| Fax |
|
| Email |
md@pkhil.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shan Sasidharan |
| Designation |
Director Research and Development |
| Affiliation |
Pankajakasthuri Herbal research Foundation |
| Address |
Department of R&D, Room No.2, Pankajakasthuri Herbal research Foundation Pankajakasthuri
Ayurveda Medical college Kattakkada Trivandrum
Thiruvananthapuram
KERALA
695572
India |
| Phone |
9188325339 |
| Fax |
|
| Email |
drshan@pkhil.com |
|
Details of Contact Person
Public Query
|
| Name |
DrJHareendran Nair |
| Designation |
Managing Director and Founder |
| Affiliation |
Pankajakasthuri Herbal research Foundation |
| Address |
Department of kayachikitsa,Room No 1, Pankajakasthuri Herbal research Foundation Pankajakasthuri
Ayurveda Medical college Kattakkada Trivandrum
Thiruvananthapuram
KERALA
695572
India |
| Phone |
9447096201 |
| Fax |
|
| Email |
md@pkhil.com |
|
|
Source of Monetary or Material Support
|
| Pankajakasthuri herbal research foundation, Killy, kATTAKADA, Thiruvananthapuram, Kerala, India |
|
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Primary Sponsor
|
| Name |
Pankajakasthuri herbal research foundation |
| Address |
Pankajakasthuri Ayurveda Medical college Kattakkada Trivandrum |
| 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 |
| DrJHareendran Nair |
Pankajakasthuri Ayurveda Medical college Kattakkada Trivandrum |
Department of Kayachikitsa
Room No. 1
Pankajakasthuri
Ayurveda Medical college and PG centre Kattakkada Trivandrum
Pankajakasthuri Ayurveda Medical college and PG centre
Kattakkada
Thiruvananthapuram
Thiruvananthapuram
KERALA |
9447096201
md@pkhil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee of Pankajakasthuri Herbal Research Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B972||Coronavirus as the cause of diseases classified elsewhere. Ayurveda Condition: A type of Jwara (Kapha-Vata-Samasargaj-Jawara i.e. Sannipataj-Jawara)), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: PulmoCard caps , Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 400(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: Hot water), Additional Information: Each 400 mg cap was prepared from extract of
Calotropis gigantea (Swetha Arka Pushpa)-200 mg
Piper nigrum (Maricham)- 100mg
Curcuma longa (Nisa)- 100 mg
(One cap TDS)(2) Medicine Name: Acalogen caps, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 400(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: Hot water), Additional Information: Acalypha indica (Kuppameni)-200mg
Trikatu- 25 mg each
Myristica fragrans (Nutmeg) - 50mg
Andrographis paniculata (Kiriyathu) - 50 mg
Curcuma longa (Nisa)- 25 | | 2 | Comparator Arm (Non Ayurveda) | | - | Non ayurveda | Paracetamol (Tab) 500mg/BD |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients tested positive for Covid-19 using RTPCR.
2. Willing and able to provide written informed consent prior to performing study procedures by the subject or legal guardian.
|
|
| ExclusionCriteria |
| Details |
1. Subject or Authorized Representative is unable to provide informed consent.
2. Subject is pregnant or breastfeeding ladies.
3. Subject is of childbearing potential and has a positive pregnancy test since admission to the hospital.
4. Intra-thoracic or intra-abdominal surgery within the 12 hours prior to consent, or ongoing impairment of hemostasis as a result of one of these procedures.
5. A history of head trauma, spinal trauma, or other acute trauma with an increased risk of bleeding.
6. Cerebral Vascular Accident (CVA) or Intracerebral
Arteriovenous Malformation (AVM), cerebral aneurysm, or mass
lesions of the central nervous system or melena, hematemesis.
7. Inability to take oral medication
8. Prolonged QTc-interval in baseline ECG (>500 ms)
9. History of solid organ, allogeneic bone marrow, or stem cell transplantation.
10. Severe renal failure characterized by chronic or acute need of hemodialysis, hemofiltration or peritoneal dialysis.
11. Need of anticoagulants, antiplatelet agents, anti-thrombotics and thrombolytics during the treatment period.
12. Participation in another research study involving an investigational agent within 30 days prior to consent.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the efficacy of Ayurveda treatment protocol in management of Covid-19 and PostCovid complication.
2. To determine the safety of the Ayurveda treatment protocol.
3. To assess the time taken for RTPCR to become negative and normalization of all clinical sign |
During the therapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the effect of the treatment protocol in blood coagulation profile.
2. To evaluate the effect of the treatment protocol in complete blood count and basic
inflammatory markers.
3. To evaluate the effect of the treatment protocol in Vitals of the subjects. (BP, HR, PR, RR, SpO2)
4. To check the impact and role of ayurvedic treatment in the changes of radiological/CT imaging scans of major organs like lungs/brain after Covid-19 infection. |
During the therapy |
|
|
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 4 |
|
Date of First Enrollment (India)
|
23/07/2021 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The
COVID 19 is now spreading throughout the world because of its high infectivity
and communicability. Also, there is a lack in the proper management of the
disease. So, any contribution in the knowledge of treatment of COVID 19 from
any source could be of great value to the medical profession. Thus, the present
study is proposed to understand the safety and efficacy of Ayurveda therapy
protocol in managing the patients infected with SARS COV2/COVID 19 infection.
The treatment protocol comprises a blend of poly herbo mineral formulations,
which is formulated with the help of antiviral phytomolecules and processed and
purified natural metallic compounds as per Ayurveda principles. The drug used
in the treatment protocol comprises systematic herbal formulations with
appropriate combinations, which are reported to have remarkable antiviral,
antipyretic, immunomodulatory effects in treating patients. In the present
prospective, interventional, single-arm clinical trial to evaluate the efficacy
and safety of Ayurveda therapy protocol as a standalone antiviral therapy
managing mild to moderate COVID-19 patients and its post complications. This Ayurveda
therapy protocol consist of a combination of three drugs and an eye drops i.e. PulmoCard
caps, Acalogen caps, Opthoxy eye drops and ZingiVir-H tablets. Adult subjects
who meet all inclusion criteria with COVID 19 positive assessment and mild
COVID 19 infection-related symptoms shall be screened into the study. In the
present prospective, interventional, single-arm clinical trial to evaluate the
efficacy and safety of Ayurveda therapy protocol in the management of mild to
moderate COVID-19 patients and its post complications. During this study, we
will know the efficacy and safety of Ayurveda therapy protocol in the
management of COVID-19 and its Post complications. Further, we can assess the
time taken for RTPCR to become negative and normalize all clinical signs. In
addition to this, we will also measure the following during the study period.
1. To evaluate the effect of the treatment protocol in the blood coagulation
profile. 2. To evaluate the effect of the treatment protocol in complete blood
count and basic inflammatory markers. 3. To evaluate the effect of the
treatment protocol on the Vitals of the subjects. (BP, HR, PR, RR, SpO2).
Safety assessments will be done by assessing any adverse events or SAE in the
study patients during the treatment period. Paper CRF shall be used in the
study for data collection. Statistical analysis shall be done, and the study
results shall be published. A clinical study report shall be prepared and will
be submitted to relevant regulatory authorities.
|