| CTRI Number |
CTRI/2024/09/073489 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
30/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Diagnostic
Screening |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To evaluate the effectiveness of Varuna leaves paste in conjunction with ghee following a cow dung massage, as well as the comparison between Varuna leaves siddha ghee and Manjistha ghee in the treatment of stretch marks |
|
Scientific Title of Study
|
Evaluation of comparative efficacy of external application of Varuna (Crataeva nurvala Buch-Ham) patra kalka with Ghrita after the Gomaya Gharsgana, Varuna patra Siddha Ghrita and Manjistha Ghrita in the management of Striae Gravidarum (Kikkisa): Three arm study |
| 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 Pallavi Dewangan |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha |
| Address |
Department of dravyaguna vigyan Mahatma Gandhi Ayurved College and Research Centre Salod Wardha 442001
wardha Maharashtra 442001 india
Mahatma Gandhi Ayurved College and Research Centre Salod Wardha 442001
wardha Maharashtra 442001 india
Wardha
MAHARASHTRA
442001
India |
| Phone |
7691928631 |
| Fax |
|
| Email |
pallavidewangan2411@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jaimala Jadhav |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha |
| Address |
Department of dravyaguna vigyan Mahatma Gandhi Ayurved College and Research Centre Salod Wardha 442001
wardha Maharashtra 442001 india
Mahatma Gandhi Ayurved College and Research Centre Salod Wardha 442001
wardha Maharashtra 442001 india
Wardha
MAHARASHTRA
442001
India |
| Phone |
9922190843 |
| Fax |
|
| Email |
jaymalajadhav0610@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pallavi Dewangan |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha |
| Address |
Department of dravyaguna vigyan Mahatma Gandhi Ayurved College and Research Centre Salod Wardha 442001
wardha Maharashtra 442001 india
Mahatma Gandhi Ayurved College and Research Centre Salod Wardha 442001
wardha Maharashtra 442001 india
Wardha
MAHARASHTRA
442001
India |
| Phone |
7691928631 |
| Fax |
|
| Email |
pallavidewangan2411@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha (Maharashtra) 442001 |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha |
| Address |
Department of Dravyaguna vigyana Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha 442001 |
| 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 |
| Dr Pallavi Dewangan |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha 442001 |
Deoartment of Dravyaguna vigyan Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha(Maharashtra) 442001
Wardha
MAHARASHTRA |
7691928631
pallavidewangan2411@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurved College Hospital and Research Centre Institutional Ethics Committee Salod Wardha |
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: KIKKISA-GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Varuna Patra, Reference: Bhaishajya ratnavali, Route: Topical, Dosage Form: Lepa Churna, Dose: 0(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: this is a three arm study first group will be having 20 patient with intervention of Varuna Patra | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Varuna Patra Siddha Ghrita, Reference: Bhaishajya ratnavali, Route: Topical, Dosage Form: Ghrita, Dose: 0(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: this is a three arm study second group will be having 20 patient with intervention of Varuna Patra Siddha Ghrita | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Manjistha Ghrita, Reference: Charak Samhita, Route: Topical, Dosage Form: Ghrita, Dose: 0(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: this is a three arm study the comparator group contain Manjistha Ghrita with 20 patient all the three groups run parallel for 8 weeks |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Female Patient willing to participate with written informed consent.
2. Age group between 25-45 years.
3. 2 years history of last delivery.
4. no prior treatment for Kikkisa before 1 month. |
|
| ExclusionCriteria |
| Details |
1. pregnant women.
2. Lactating women.
3. Any type of skin disease other than Kikkisa.
4. Patient having chronic disease eg. tuberculosis, jaundice etc
5. Any malignancy on the affected part was excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To eliminate the Striae Gravidarum (Kikkisa) in Garbhani rog. |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Varuna Patra kalka with Ghrita after the Gomaya Gharshana, Varuna Patra Siddha Ghrita and Manjistha Ghrita in management of Garbhani rog (Kikkisa) |
8 weeks |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
24/11/2024 |
| 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="2"
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 volunteers will be informed about the study protocol. Willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, MGACHRC, Salod wardha and CTRI registration will be done. After selection, each participant will be tested individually and selected according to selection criteria. They are divides into three group the trial is a randomized parallel arm clinical trial. It will include 8 weeks treatment period and follow up. |