| CTRI Number |
CTRI/2025/03/081985 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Understanding the Aashaya Apkarsha Principle in Charaka Samhita with Etiopathogenesis and Management of Vyanga (Melasma) with Vyanganashaka Lepa and Gharshana Karma (Hydra Derma Abrasion) |
|
Scientific Title of Study
|
Critical review of Kiyanta Shiraseeya Adhyaya of Charaka Samhita w.s.r to Aashaya Apkarsha Siddhanta and its role in Etiopathogenesis and Management of Vyanga (Melasma) with Vyanganashaka Lepa and Gharshana Karma (HDA). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Rajesh Kumar Sood |
| Designation |
Professor |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola |
| Address |
Room no. 405 Department of Samhita Siddhant and Sanskrit, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7018785200 |
| Fax |
|
| Email |
drrajeshsood@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Rajesh Kumar Sood |
| Designation |
Professor |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola |
| Address |
Room no. 405 Department of Samhita Siddhant and Sanskrit, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7018785200 |
| Fax |
|
| Email |
drrajeshsood@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manisha Chauhan |
| Designation |
PG Scholar |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola |
| Address |
Room no. 405 Department of Samhita Siddhant and Sanskrit, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9816196255 |
| Fax |
|
| Email |
chauhanmanisha477@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy, RGGPG Ayurvedic College and Hospital Paprola District Kangra H.P. 176115
Research Institute in I.S.M JoginderNagar Distt. Mandi H.P. 175015 |
|
|
Primary Sponsor
|
| Name |
RGGPG Ayurvedic College |
| Address |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Himachal Pradesh 176115 |
| 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 |
| Prof Dr Rajesh Kumar Sood |
Rajiv Gandhi government post graduate ayurvedic College |
OPD no. 715 Skin Care Unit Derma Research Lab Hospital Block Kangra HIMACHAL PRADESH Kangra HIMACHAL PRADESH
Kangra
HIMACHAL PRADESH |
7018785200
drrajeshsood@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC(Human)RGGPG Ayurvedic College Paprola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L811||Chloasma. Ayurveda Condition: VYANGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Lepa | (Procedure Reference: A.H.Ut. 32/18-19, Procedure details: The paste of powdered drug will be applied with milk (QS) once in morning time.)
(1) Medicine Name: Vyanganashaka Lepa, Reference: A.H.Ut. 32/18-19, Route: Topical, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: od, Duration: 45 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | HDA (Hydra Derma Abrasion) | Patient will be managed with Hydra Derma Abrasion (Gharshana karma) once in every 15 days. | | 3 | Comparator Arm | Procedure | - | Lepa | (Procedure Reference: A.H.Ut.32/18-19, Su. chi. 20/33-34, Procedure details: To evaluate efficacy of Gharshana karma (Hydra Derma Abrasion, HDA) along with Vyanganashaka leap.)
(1) Medicine Name: Vyanganashaka leap. Hydra Derma Abrasion, Reference: A.H.Ut.32/18-19, Su. chi. 20/33-34, Route: Topical, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: od, Duration: 45 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to participate.
Patients with classical sign and symptoms of Vyanga -
Mandala
Niruja
Shyava
Tanu
Patients between age of 18-60 years .
Patients examined and assessed by detailed history.
|
|
| ExclusionCriteria |
| Details |
Patients not willing to participate .
Patients less than 18 and more than 60 years of age.
Hyperpigmentation due to
malignant melanomas
present since birth, Pregnant women,
Patients taking hormonal pills,
Patients having other facial skin diseases.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Overall improvement which will be shown by the patients in signs and symptoms of Melasma. |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Overall improvement which will be shown by the patients in signs and symptoms of Vyanga. |
60 days |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
02/05/2025 |
| 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="6"
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
|
Dermatology is not a seperate branch or specialization in Ayurveda, still we have sufficient
literature pertaining to various skin disorders and their individual features mentioned here and there. In the present study it will be tried to scrutinize about Melasma (vyanga) and its management mentioned in Samhitas. The clinical part of the study is aimed at treatment of Vyanga (Melasma) with Vyanganashaka Lepa and Hydra Derma Abrasion (HDA). |