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CTRI Number  CTRI/2024/10/075650 [Registered on: 22/10/2024] Trial Registered Prospectively
Last Modified On: 30/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative pharmacological and clinical study of Shatahva oral and local application on wrinkle. (One group without oral and another group having both oral and local application) 
Scientific Title of Study   Randomized Open Labelled Prospective Comparative Pharmaco-Clinical Study to assess the efficacy of Shatahva (Anethum graveolens L.) Topically in the reduction of Vali –wrinkle with and without oral dosage form 
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 Shivangi Mishra 
Designation  Assistant Professor (PhD. Scholar) 
Affiliation  Dr. D.Y Patil deemed to be University. School of Ayurveda.  
Address  Dr. D.Y Patil deemed to be University. School of Ayurveda. Department of Dravyaguna. Nerul. Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  9619422910  
Fax    
Email  shivangi.mishra@dypatil.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Shraddha Nayak 
Designation  Associate Professor 
Affiliation  Dr. D.Y Patil deemed to be University. School of Ayurveda.  
Address  Dr. D.Y Patil deemed to be University. School of Ayurveda. Department of Dravyaguna. Nerul. Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  9619016727  
Fax    
Email  shraddha.nayak@dypatil.edu  
 
Details of Contact Person
Public Query  
Name  Dr Shraddha Nayak 
Designation  Associate Professor 
Affiliation  Dr. D.Y Patil deemed to be University. School of Ayurveda.  
Address  Dr. D.Y Patil deemed to be University. School of Ayurveda. Department of Dravyaguna. Nerul. Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  9619016727  
Fax    
Email  shraddha.nayak@dypatil.edu  
 
Source of Monetary or Material Support  
SELF 
 
Primary Sponsor  
Name  Dr DY Patil deemed to be University School of Ayurveda Nerul Navi Mumbai 
Address  Dr. D.Y Patil deemed to be University. School of Ayurveda. Nerul. Navi Mumbai- 400706 India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shivangi Mishra  D. Y. Patil Ayurvedic Hospital  D.Y. Patil School of Ayurveda. Department of Dravyaguna. OPD no-02. D. Y. Patil Ayurvedic Hospital. Nerul. Navi Mumbai- 400706.
Thane
MAHARASHTRA 		 9619422910

shivangi.mishra@dypatil.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  a) ICD 10. L90.6 Wrinkle. Ayurveda (Vali) 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Shatahva (Anethum graveolens), Reference: Kashyap Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: Ghrita), Additional Information: NA
2Comparator ArmDrugClassical(1) Medicine Name: Shatahva, Reference: Kashyap Samhita, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: Local application- Sayam kaal
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Subjects between the age group of 30-45 years & of any Gender.
(As per Acharya Sharangdhar, Complexion is seen in the 3rd Decade i.e. after 30years of age)
2. Subjects who are showing signs of early aging such ass fine lines and wrinkles
3. Subject with Fitzpatrick skin types II to IV for Indian population.
4. Subjects with signs of ageing such as fine lines, wrinkles, spots, pigmentations, uneven skin tone, etc., subjects with mild to moderate hyperpigmentation spots (ephilides, lentigines, PIH)
5. Volunteers who are ready to avoid taking food supplements or cosmetic products for face care and do not modify their regular diet, concerning fruit or vegetable intake and are indoor during Day-time.
6. Patients who are willing and sign the informed consent form and comply with study requirements.
7. Subjects who have not participated in similar investigation in the past four weeks.
8. The study included healthy subjects with skin photo-types from I to IV who were willing to not expose their skin to both natural and artificial UV. 
 
ExclusionCriteria 
Details  1. Patient suffering from acute, Chronic and progressive disease liable to interfere with the study data like DM, HTN, Hepatitis, or any serious medical illness.
2. Cutaneous marks on the experimental areas, which could interfere with the assessment of skin reactions (pigmentation disorders, scars, thick or excess hair, freckles and nevi in great quantity, sunburn or inflammatory conditions of the facial skin, including atopic dermatitis, psoriasis, and rosacea).
3. Received any facial aesthetic treatments or oral retinoid within the last 6 months or anticipated during the study period.
4. Active skin diseases (e.g. moderate to severe acne vulgaris face or nodulocystic acne, psoriasis, active atopic dermatitis, melasma, lichen planus pigmentosus/ Ashy dermatosis, pigmented contact dermatitis or other cutaneous manifestations), with severe to chronic hyperpigmentation spots (ephilides, lentigines, PIH)
5. Subjects having personal history of cosmetic, drug or domestic products with irritative reaction.
6. Immuno-compromised patients.
7. Pregnancy and lactating mother.
8. Food allergy or food intolerance.
9. Under any treatment known to interfere.
10. Not willing to discontinue other topical facial products.
11. On medications steroids, antioxidant.
12. Any serious medical and psychological condition will be excluded. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
a)Improvement in the fine lines parameters such as Forehead lines at rest, Upper eyelid laxity, Infra orbital laxity, Visible malar prominence, Fullness of buccal fat pad, etc.
b) Improvement in the skin Characteristics and Physiological factors.
c) Improvement in the depth of the wrinkle after local application of the drug along with and without oral dosage form will be assessed at baseline, 4th week, 8th week, 12th week.  		 a)Improvement in the fine lines parameters such as Forehead lines at rest, Upper eyelid laxity, Infra orbital laxity, Visible malar prominence, Fullness of buccal fat pad, etc.
b) Improvement in the skin Characteristics and Physiological factors.
c) Improvement in the depth of the wrinkle after local application of the drug along with and without oral dosage form will be assessed at baseline, 4th week, 8th week, 12th week.  
 
Secondary Outcome  
Outcome  TimePoints 
1)Improvement in skin firmness, skin texture & visible pores, in comparison & assessed at baseline, 4th week, 8th week, 12th week.
2)The Product efficacy of the drug, Product Usability, safety Evaluation will also be done & assessed at baseline, 4th week, 8th week, 12th week. 		 1)Improvement in skin firmness, skin texture & visible pores, in comparison & assessed at baseline, 4th week, 8th week, 12th week.
2)The Product efficacy of the drug, Product Usability, safety Evaluation will also be done & assessed at baseline, 4th week, 8th week, 12th week. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/11/2024 
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  

TITLE OF STUDY

 

“RANDOMIZED OPEN LABELLED PROSPECTIVE COMPARATIVE PHARMACO-CLINICAL STUDY TO ASSESS THE EFFICACY OF SHATAHVA (ANETHUM GRAVEOLENS L.) TOPICALLY IN THE REDUCTION OF VALI –WRINKLE WITH AND WITHOUT ORAL DOSAGE FORM”

 

Background and Trial purpose of study:

Wrinkle, a major symptom of skin aging is a slow process that is linked to the loss of several basic skin characteristics like loss of skin elasticity and hydration. An inclusive approach targeting homeostasis internally as well as externally is needed in imparting anti-aging attributes. The Synthetic antioxidants damage the liver and other organs due to their toxic effects.

Therefore, the preparation of new effective natural antioxidant to rejuvenate the skin is very important and it is imperative to find a ubiquitous and inexpensive natural extract that can be used as an active ingredient.

In this study, Shatahva (Anethum graveolens L.) oral and Topical application is used. The phyto-pharmacological works on Shatahva (Anethum graveolens L.) have been widely explored and is known to have Antioxidant, Anti-inflammatory, and nutrient-rich properties suggesting its potential in promoting skin health and supporting collagen metabolism.

 

 

AIM & OBJECTIVES

AIM:

 

·             To compare the efficacy of Shatahva (Anethum graveolens L.) Topically in the management of Vali –Wrinkle with and without oral dosage form.

 

PRIMARY OBJECTIVES:

 

·             To determine the comparative impact between oral and topical application with topical application of Shatahva (Anethum graveolens L.) in the reduction of signs of ageing and tracking the improvement with reference to Vali (wrinkle) in comparison to baseline.

 

SECONDARY OBJECTIVES:

 

·             To conduct Pharmacognostical analysis of the dosage form of Shatahva and to understand probable pharmacological action in Ayurveda and conventional medicine.

·             To assess the safety and acceptance of the test product, in comparison to baseline.

·             To critically review relevant literature on Shatahva, Vali, wrinkle from available Ayurveda classical texts as well as modern texts.

 

RESEARCH QUESTION AND HYPOTHESIS

 

RESEARCH QUESTION:

·             Is there any significant difference between the efficacy of oral and topical application over topical application of Shatahva (Anethum graveolens L.) in improving outcome of Vali (wrinkle)?

 

HYPOTHESIS:

NULL HYPOTHESIS (H0):

·             There is no significant difference in the efficacy of Shatahva used Combined oral and topical with topical application in the management of vali (wrinkle).

 

ALTERNATIVE HYPOTHESIS (H1):

·             There is a significant difference in the efficacy of Shatahva used Combined oral and topical with topical application in the management of vali (wrinkle).

 

METHODOLOGY

Source of Patients – Healthy Volunteers willing to give consent will be enrolled for the study. Population for the study will be identified from those attending OPD & IPD of D.Y. Patil College, School of Ayurveda & Hospital and those willing for informed consent will be enrolled in the study.

 

ETHICAL CLEARANCE: Ethical clearance will be taken from ethical committee of D. Y. Patil Ayurvedic Hospital. Nerul.

 

TYPE OF STUDY: Interventional Clinical study

 

STUDY DESIGN: Double Arm Open prospective Randomized clinical Study.

 

SAMPLE SIZE – 100

 

WRITTEN AND INFORMED CONSENT: Before taking part in the study, volunteers will be asked for written agreement in a language they can understand, and volunteers will be informed about the investigation.

 

FOLLOW UP: Clinical Assessment will be done with baseline investigation and monthly primary outcome will be observed for 3 months.

 

COLLECTION OF MATERIAL: The entire Shatahva plant will be cultivated and Procured from Natural Habitat in accordance with Good Agriculture and collection Practices and verified during the fruiting season in Shishira Ritu, which occurs in the fall, the transitional season between summer and winter. The drug will be authenticated and Standardized from Authentic Laboratory before trial.

 

SOP for PREPARATION OF DOSAGE FORM

DRAVYA

LATIN NAME

FAMILY

RASA

GUNA

VIRYA

VIPAKA

PART USED

Shatahva24

Anethum graveolens L.

 Apiaceae

Madhura, Katu, tikta

Laghu, ruksha, tikshna

Sheeta

Madhura

Fruit

Goghrita25

 

 

Madhura

Laghu, Snigdha, mrudu

Sheeta

Madhura

 

 

DOSE OF DRUG:

DOSE: 3-6 gm (Modified into convenient dosage form)

ANUPANA: Ghrita

BHESHAJA KALA: Internal- Annanakala (Rasayana kala)

                                    Topical- Sayam (Evening)

DURATION -12 weeks

MODE OF ADMINISTRATION: Oral along with Topical Cream Application.

 

Sampling Technique-As the study is carried out in Healthy volunteers, empirically 100 subjects will be considered.

 

Experimental Drug

Experimental Drug

Medicine

Shatahva

Shatahva

Sample size

50

50

Route of Drug Administration

Oral along with Topical Application

Topical Application

Duration

12 weeks (Approx. 90days)

12 weeks (Approx. 90days)

Assessments

Initial day 0th day, 30th day, 60th day, 90th day.

Initial day 0th day, 30th day, 60th day, 90th day.

 

 

ASSESSMENT CRITERIA

 

·             Subjective assessment for the application site reaction:

        Signs & Symptoms:

1.   Skin firmness, Skin texture, visible pores, Evenness of skin tone and skin hydration

2.   Overall wrinkles over face

3.   Crow’s feet grading scale in unanimated face

4.   Naso-labial folds

5.   Frown lines

6.   Homogeneity of age spots

7.   Pores

8.   Skin clarity

9.   Skin smoothness

10. Evenness of skin


 
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