| CTRI Number |
CTRI/2020/10/028659 [Registered on: 27/10/2020] Trial Registered Prospectively |
| Last Modified On: |
20/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study Of Efficacy Of Punarnavashtaka Kwatha In The Management of Anaemia. |
|
Scientific Title of Study
|
Randomised Control Clinical Study Of Efficacy Of Punarnavashtaka Kwatha In The Management of Kaphaj Pandu. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Deepak Deochand Bhoyar |
| Designation |
PG Scholar |
| Affiliation |
Bharatiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya |
| Address |
Department Of Kayachikitsa, Bharatiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya, Vishwashanti dham, Kesnand road, Wagholi, Pune-412207
Bharatiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya, Vishwashanti dham, Kesnand road, Wagholi, Pune-412207
Pune
MAHARASHTRA
412207
India |
| Phone |
7875861261 |
| Fax |
|
| Email |
drdeep.bhoyar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Anjali A Deshpande |
| Designation |
Professor & HOD of Kayachikitsa |
| Affiliation |
Bharatiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya |
| Address |
Department Of Kayachikitsa, Bharatiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya, Vishwashanti dham, Kesnand road, Wagholi, Pune-412207
Bharatiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya, Vishwashanti dham, Kesnand road, Wagholi, Pune-412207
Pune
MAHARASHTRA
412207
India |
| Phone |
9730069747 |
| Fax |
|
| Email |
anjalidesh1610@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Anjali A Deshpande |
| Designation |
Professor & HOD of Kayachikitsa |
| Affiliation |
Bharatiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya |
| Address |
Department Of Kayachikitsa, Bharatiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya, Vishwashanti dham, Kesnand road, Wagholi, Pune-412207
Bharatiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya, Vishwashanti dham, Kesnand road, Wagholi, Pune-412207
MAHARASHTRA
412207
India |
| Phone |
9730069747 |
| Fax |
|
| Email |
anjalidesh1610@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharatiya Sanskriti Darshan Trusts Ayurved Hospital & Research Center, Vishwashanti Dham, Kesnand Road, Wagholi, Pune-412207 |
|
|
Primary Sponsor
|
| Name |
BSDTs Ayurved Hospital Research Center Wagholi Pune |
| Address |
BSDTs Ayurved Hospital & Research Center, Vishwashanti Dham, Kesnand Road, Wagholi, Pune-412207 |
| 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 |
| Vd Deepak Deochand Bhoyar |
Bharatiya Sanskriti Darshan Trusts Ayurved Hospital & Research Center, Wagholi, Pune |
OPD No.1, department of Kayachikitsa, Bharatiya Sanskriti Darshan Trusts Ayurved Hospital & Research Center, Vishwashanti Dham, Kesnand Road, Wagholi, Pune-412207
Pune
MAHARASHTRA |
7875861261
drdeep.bhoyar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D758||Other specified diseases of bloodand blood-forming organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A-Punarnavashtaka Kwatha |
Group A-Punarnavashtaka Kwatha 40ml in Vyanodaan kala orally for 28 days will be given to 32 patients diagnosed with Kaphaj Pandu with assessment on 0th, 15th, 29th day. |
| Comparator Agent |
Group B-Navayasa Loha Vati |
Group B-Navayasa Loha Vati 500mg in Vyanodaan kala along with koshna jala will be given orally for 28 days to 32 patients diagnosed with Kaphaj Pandu .Assessment will be done on 0th, 15th, 29th day. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
(1) Patient having signs and symptoms of Kaphaj Pandu (Panduta, Akshikootshoth, Hridspandan, Gauravta, Chardi) more than 1 to 2 months.
(2) Hb % of either gender between 7-11gm/dl will be selected. |
|
| ExclusionCriteria |
| Details |
Mrudbhakshanjanya Pandu
Garbhinijanya Pandu
Sannipataka Pandu
K/c/o Aplastic Anaemia, Sickle cell Anaemia like disorder.
Patient with severe systemic disorders and surgical illnesses.
Patient with Haemorrhagic disorders.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
(1) To Observe and document the effect of Punarnavashtaka kwatha in the management of Kaphaj Pandu.
(2) To Observe and document the effect of Punarvashtaka kwatha in Signs and symptoms of Kaphaj Pandu.
|
0th, 15th, 29th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
(1) To find out the adverse effect of Punarnavashtaka Kwatha if any.
(2) To assess the effect of Punarnavashtaka Kwatha by Biochemical investigation. |
0th, 29th day |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
30/10/2020 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The current study is a randomised control parallel group trial comparing the efficacy of Punarnavashtaka Kwatha 40 ml in Vyanodaan kala with Navayas Loha Vati 500 mg in Vyanodaan kala for 28 days duration. Each group comprising of 32 patients diagnosed as Kaphaj Pandu. Assessment will be done on the 0th, 15th, 29th day. Considering the increased flow of patients coming to the OPD with complaints of Gauravta, Chhardi, Prasek, Bhram, Klama, Aruchi, Alasya etc this study has been selected. Santarpanjanya hetu like Junk food, Paryushit anna, Atyambupan, Guru ahara, Sedentary lifestyle, Mental stress, etc mentioned by our Ayurved classics are relevant even in todays era. Punarnavashtak Kwatha a simple formulation has been described in the Ayurvedic text of Bhaishajya Ratnavali- Shotha roga chikitsa prakaran, 42/13. This kalpa mainly consists of ingredients which acts as Kaphaghna, Pittashamak, Raktavardhak, Deepana, Pachana, Yakrutottejak and Krumighna thus helping to break the samprapti of Pandu. Punarnavashtak Kwath being easily available, easily palatable, so I have selected this drug for this study. |