| CTRI Number |
CTRI/2022/05/042381 [Registered on: 05/05/2022] Trial Registered Prospectively |
| Last Modified On: |
04/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical and comparative study of sarivadaya azalea saptachchhadadi taila and pranayam in the management of melasma |
|
Scientific Title of Study
|
A clinical and comparative study of sarivadya avaleha saptachchhadadi taila and pranayam in the management of vyanga vyadhi |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shweta Kuldeep |
| Designation |
MD scholar |
| Affiliation |
Shri Narayan Prasad Awasthi Government Ayurved College, Raipur, Chhattisgarh |
| Address |
Department of kayachikitsa, Shri Narayan Prasad Awasthi Government Ayurved College Raipur, Chhattisgarh
Shri Narayan Prasad Awasthi Government Ayurved College, Raipur, Chhattisgarh
Raipur
CHHATTISGARH
492010
India |
| Phone |
7024536838 |
| Fax |
|
| Email |
shwetakuldeep22492@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aruna Ojha |
| Designation |
Professor |
| Affiliation |
Shri Narayan Prasad Awasthi Government Ayurved College, Raipur, Chhattisgarh |
| Address |
Department of kayachikitsa Shri Narayan Prasad Awasthi Government Ayurved College, Raipur, Chhattisgarh
Shri Narayan Prasad Awasthi Government Ayurved College, Raipur, Chhattisgarh 492010 India
Raipur
CHHATTISGARH
492010
India |
| Phone |
9424401858 |
| Fax |
|
| Email |
arunaojha90@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi Diwan |
| Designation |
Lecturer |
| Affiliation |
Shri Narayan Prasad Awasthi Government Ayurved College, Raipur, Chhattisgarh |
| Address |
Department of kayachikitsha Shri Narayan Prasad Awasthi Government Ayurved College, Raipur, Chhattisgarh
Shri Narayan Prasad Awasthi Government Ayurved College, Raipur, Chhattisgarh 492010
Raipur
CHHATTISGARH
492010
India |
| Phone |
9770933579 |
| Fax |
|
| Email |
rashmi.diwan3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kayachikitsa shri. Narayan Prasad Awasthi Govt. Ayurved College raipur CG |
|
|
Primary Sponsor
|
| Name |
Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur Chhattigarh |
| Address |
Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh |
| Type of Sponsor |
Other [Government Ayurved College Raipur Chattisgarh ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Rashmi Diwan |
Lecturer in Dept. of KaychikitsaShri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shweta Kuldeep |
Shri Khudadad Doongaji Goverment Ayurved Hospital Raipur Chhattisgarh 492010 |
Department of Kayachikitsa OPD- 2 and 18 and IPD -patient Shri Khudadad Doongaji Goverment Ayurved Hospital Raipur Chhattisgarh 492010
Raipur
CHHATTISGARH |
7024536838
shwetakuldeep22492@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE OFFICE OF THE PRINCIPAL ,SHRI NARAYAN PRASAD AWASTHI GOVERMENT AYURVED COLLEGE RAIPUR |
Approved |
| intitutional ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: VYANGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: saptachchhadadi taila , Reference: bhaishjyaratnawali, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: This medicated oil made from saptaparn, nimb, haridra, daruharidra, amalki and vibhitka. These all drugs are mostly vatt and pitta shamak and vyangavyadhi formed by vatta pitta dushti, so may be this medicated oil will be beneficial for vyanghavyadhi. | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Sarivadya avaleha, Reference: Bhaishajyaratnawali, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -with milk), Additional Information: This avaleha will be made from sariva, giloy, satavari, vikarikanda, jivak, haritki, amalaki and elaichi. These all drugs are mainly vatta pitta shamak, and we know vyangavyadhi occur by vatta pitta dushti. So, this drug may be beneficial for vyangavyadhi. [ | | 3 | Comparator Arm | Procedure | - | Bhramri Pranayam | (Procedure Reference: Gherand Samhita, Procedure details: Half hour two times a day in morning and evening for three (3) month duration.)
(1) Medicine Name: Sarivadyaavelha and Sappachchadadi taila, Reference: Bhaisjya Ratnavali, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: od, Duration: 3 Months |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age under 18 to 60 years,symptoms given in the textbook of ayurveda |
|
| ExclusionCriteria |
| Details |
Age below 18 and above 60 years, any type of allergy in skin, skin in cancer, |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Readuction in melasma area and severity index in 12 week changes in face skin colour in 12 week |
12 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to improve quality of facial skin |
90 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/05/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Vyanga is a disease caused by vata pitta deformity,sarivadya avaleha is rasayana deepan vata pitta shamak and Saptachchhadadi taila is kusthaghn raktashodhak chedan krimighn and vanya and by vata pitta it naturalizes the complexion of the skin. Mental stress is one of the main causes of vyanga vyadhi.Pranayama has an effect on the mind as well as the body.due to this sattva reduces stress by adopting equilibrium in raja tama. This vyadhi does not couse any kind of physical pain makes the mentally patient very upset in a tropical country like india. There are most of the women in the society suffering from this condition but there is no effective treatment in any pathy. In modern medical science,many types of creams, steroids, hydroqvicones, corticosteroids etc are used for medicine and along with it procedure like Dermabration, microdermabration, laser therapy, Chemical pilling etc are also used.due to the cost of the procedure being expensive, women of every category can not afford the treatment for this disease. Patients are spent money and time on both but they does not get the expected benefit and than the patient keeps going from one doctor to another doctor to cure this disease and some time reaches a state of depression.Vyanga is a disease caused by vata pitta disorder, in which I will use Sarivadya for internal use and Saptachchhadadi taila for external use, the substances present are mainly vata pitta shamak and rasayan, there fore external and internal therapy of the skin will be use in research. Therefore I have chosen Sarivadya avaleha Saptachchhadadi taila and Pranayam so that affordable, accessible and satisfactory medical treatment can be provided to women of all classes. |