| CTRI Number |
CTRI/2024/11/076907 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
15/11/2024 |
| 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 Kameshwar rasa in the managment of Anemia. |
|
Scientific Title of Study
|
Randomized controlled clinical trial to study the efficacy of Kameshawar Rasa in the management of kaphaj pandu |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Mayur Bharat Patil |
| Designation |
PG Scholar |
| Affiliation |
Bhartiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya |
| Address |
Department of Kayachikitsa ,Bhartiya sanskriti Darshan Trusts
Ayurved Mahavidyalaya,Vishwashanti Dham Kesanand Road,
Wagholi,Pune-412207 Maharashtra
Pune
MAHARASHTRA
412207
India
Pune
MAHARASHTRA
412207
India |
| Phone |
7021605616 |
| Fax |
|
| Email |
mayurpatil77985@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Sushrut S Sardeshmukh |
| Designation |
Associate Professor of Kayachikitsa |
| Affiliation |
Bhartiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya |
| Address |
Bhartiya sanskriti Darshan Trusts
Ayurved Mahavidyalaya,Vishwashanti Dham Kesanand Road,
Wagholi,Pune-412207 Maharashtra
Pune
MAHARASHTRA
412207
India
Pune
MAHARASHTRA
412207
India |
| Phone |
9011074077 |
| Fax |
|
| Email |
ayuharmony@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Sushrut S Sardeshmukh |
| Designation |
Associate Professor of Kayachikitsa |
| Affiliation |
Bhartiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya |
| Address |
Bhartiya sanskriti Darshan Trusts
Ayurved Mahavidyalaya,Vishwashanti Dham Kesanand Road,
Wagholi,Pune-412207 Maharashtra
Pune
MAHARASHTRA
412207
India
MAHARASHTRA
412207
India |
| Phone |
9011074077 |
| Fax |
|
| Email |
ayuharmony@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self funded, Post Graduate Student at
Bhartiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya Vishawashanti dham kesanand road
Wagholi 412207 Pune
India |
|
|
Primary Sponsor
|
| Name |
Dr Mayur Patil Post Graduate Student at Bhartiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya |
| Address |
Bhartiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya Vishawashanti dham kesanand road
Wagholi Pune 412207
Maharashtra
India |
| Type of Sponsor |
Other [] |
|
|
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 Mayur Bharat Patil |
Bhartiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya Wagholi Pune |
OPD number 1 and IPD of Kayachikitsa Department
Pune
MAHARASHTRA |
7021605616
mayurpatil77985@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:D649||Anemia, unspecified. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kameshwar Rasa, Reference: Sartha Rasa Ratnakar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Goghruta), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Navayas loha vati, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Honey), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having lakshanas Shwetavbhasata, Akshikutashotha, Hridayaspandan, Shwasa, Gaurava, Bhrama, Klama, Praseka, Aruchi, Alasya.
2. Patients having any 3-4 lakshanas will be enrolled in the study.
3. Patients of any gender will be selected between age group 18 to 60 yrs.
4. Hemoglobin percentage -Female -6-11gm/dl and Male-7-12gm/dl. |
|
| ExclusionCriteria |
| Details |
1. Known case of Aplastic Anemia, Sickle cell Anemia.
2. Pregnant women, lactating mothers.
3. Patients with hemorrhagic disorders.
4. Patient with severe systemic disorders and surgical illness. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The effect of Kameshwar rasa in the management of Kaphaj Pandu on the basis of haemogram. |
15th day and 30th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the effect of the kameshwar Rasa & Navayas loha vati in the management of Kaphaj Pandu
To study the effect of Kameshwar Rasa by complete blood count
To observe the adverse effect of Kameshwar Rasa if any |
15th day & 30th Day |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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 |
|
Date of First Enrollment (India)
|
26/11/2024 |
| 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) |
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
|
The Current Study is Randomized Control Clinical Trial to Study the efficacy of Kameshwar Rasa In the management of Kaphaj pandu .The diagnosed patients of Kaphaj pandu will be divided Into 2 equal groups namely Experimental and Control group .The Treatment for Experimental Group is Kameshwar Rasa 500 mg, twice a day with Goghruta anupan for 30 days at Vyanodankala & Navavyas Loha vati 500 mg twice a day with anupan honey will be given to control group . Assessment will be done on 0th ,15th & 30th Day. Anemia is a major health concern worldwide .In India Anemia affects an estimated 39.8% of population Pandu roga described in ayurveda bears great resemblance to the Clinical picture of Anemia with Symptoms like Paleness all over the body ,Giddiness, Palpitations, Shortness Of Breath etc .According to Modern medicine recommended treatment for Anemia is Blood transfusion ,Iron &B12 Supplements have many side effects like constipation ,epigastric pain ,metallic taste. In Ayurveda Shaman & Shodhan chikitsa along with Nidan Parivarjan (causes eilmination) in the form of pathya apathya are recommended to treat pandu vyadhi. Kameshwar Rasa is a drug mentioned In Sartha rasa ratnakar which acts As Kaphaghna ,Vataghna, Hridya ,Ruchikara, ,Deepana ,Pachana, & helps to break Samprapti of Pandu & It is easily available & cost effective.
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