| CTRI Number |
CTRI/2026/01/101781 [Registered on: 22/01/2026] Trial Registered Prospectively |
| Last Modified On: |
26/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Drug Ayurveda Preventive |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
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Open-labeled parallel study on vyanga (hyperpigmentation) and impact of vatankura lepa and manjishtha churna (oral) along with mantra chikitsa and assessment of manasika bhava in vyanga (Hyperpigmentation) |
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Scientific Title of Study
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Assessment of manasika bhava in vyanga (melasma) and upshayatmaka effect of vatankura lepa and manjistha churna (oral) along with mantra chikitsa: an open-labeled parallel study |
| Trial Acronym |
nil |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Devashish |
| Designation |
MD scholar |
| Affiliation |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
Department of Roga Nidana Evum Vikriti Vigyan, 3rd floor, Academic block , Block C, All India Institute of Ayurveda, Gautampuri, Sarita vihar , Mathura road , New Delhi
South DELHI 110076 India |
| Phone |
09625170584 |
| Fax |
|
| Email |
dev01delhi@gmail.com |
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Details of Contact Person Scientific Query
|
| Name |
Dr Shalini Rai |
| Designation |
Associate Professor |
| Affiliation |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
Department of Roga Nidana Evum Vikriti Vigyan, 3rd floor, Academic block , Block C, All India Institute of Ayurveda, Gautampuri, Sarita vihar , Mathura road , New Delhi
South DELHI 110076 India |
| Phone |
9389423843 |
| Fax |
|
| Email |
vd.raishalini@gmail.com |
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Details of Contact Person Public Query
|
| Name |
Dr Devashish |
| Designation |
MD scholar |
| Affiliation |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
Department of Roga Nidana Evum Vikriti Vigyan, 3rd floor, Academic block , Block C, All India Institute of Ayurveda, Gautampuri, Sarita vihar , Mathura road , New Delhi
South DELHI 110076 India |
| Phone |
09625170584 |
| Fax |
|
| Email |
dev01delhi@gmail.com |
|
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Source of Monetary or Material Support
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| All India Institute of Ayurveda ,Gautampuri, Sarita vihar,Mathura road , New Delhi 110076 |
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Primary Sponsor
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| Name |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda ,Gautampuri, Sarita vihar,Mathura road , New Delhi 110076 |
| Type of Sponsor |
Research institution and hospital |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Devashish |
All India Institute of Ayurveda |
Department of Roga Nidana Evum Vikriti Vigyana,OPD ground floor,Hospital Block,All India Institute of Ayurveda,Gautampuri,Sarita vihar,Mathura road,New Delhi 110076 South DELHI |
09625170584
dev01delhi@gmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee , All India Institute of Ayurveda,New Delhi |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L814||Other melanin hyperpigmentation. Ayurveda Condition: VYANGAH, |
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Intervention / Comparator Agent
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| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | mantra-cikitsA, मन्त्र-चिकित्सा | (Procedure Reference: 19. Saini M, Gurjar A, Muthukrishnan SP, Kaur S, Sharma R, Tayade PT. Global effect on cortical activity in young Indian males in response to “OM” chanting: a high-density quantitative electro-encephalography study. Ann Neurosci. 2023 Aug 17;31(3):176–85. doi:10.1177/09727531231183219. PMID: 39156622; PMCID: PMC11325691, Procedure details: Patients will be advised to practice Om Mantra once daily between 6:00–8:00 AM on an empty stomach, after attending to natural urges, as per the SOP. They should sit comfortably with a straight back and closed eyes in a quiet, dimly lit room (or any comfortable position if unable to sit). The session will include:
5 min listening to “Om” chanting with deep breathing,
5 min quiet deep breathing,
5 min active “Om” chanting (as per Saini M. et al., 2023).
Patients will record their daily practice in the provided log and may contact the researcher for any queries during the study.
) (1) Medicine Name: Vatankura lepa, Reference: yogratnakar, Route: Topical, Dosage Form: Lepa Churna, Dose: 3(g), Frequency: od, Duration: 45 Days(2) Medicine Name: manjishtha churna, Reference: chakradutt, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Duration: 45 Days | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: vatankura lepa, Reference: yogratnakar, Route: Topical, Dosage Form: Lepa Churna, Dose: 3(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: manjishtha churna, Reference: chakradutt, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: madhu), Additional Information: - |
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
38.00 Year(s) |
| Gender |
Both |
| Details |
1) patient diagnosed with vyanga (melasma) on the basis of clinical signs and symptoms.
2) patient willing to give written informed consent and follow up.
3) Patients of age group 18-38 years irrespective of sex, religion, or occupation.
4) Disease chronicity not more than 5 yr.
5) patients with controlled hypothyroidism and diabetes.
6) patient of vyanga showing the presence of Manasika bhava in any grade.
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| ExclusionCriteria |
| Details |
1. Pregnant women and lactating mothers.
2. Patients below 18 years and above 38 yr of age.
3. Severe dermatological disorders (e.g., eczema, psoriasis).
4. Patient with uncontrolled hypothyroidism (TSH Greater than 5mIU/L) and diabetes
(HbA1c More than 6.5%).
5. Patient on hormonal therapy.
6. Patient not willing to participate in clinical trial.
7. Patient with any hearing impairment. |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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An Open list of random numbers |
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Blinding/Masking
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Not Applicable |
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Primary Outcome
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| Outcome |
TimePoints |
• A higher prevalence of Mansika Bhava is present in vyanga (melasma).
• Change in MASI (Melasma Area and Severity Index) SCALE after the treatment.
• Improvement/resolution in signs and symptoms of Vyanga (Melasma). |
for an interventional study
Percentage change of the clinical sign and symptoms of vyanga in both the groups after 45 days i.e. follow up 2 months and observing the effect of drugs on manasika bhava
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Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the therapeutic effect along with Mantra chikitsa on serum cortisol level,
and fMRI, EEG (electroencephalogram) (if the facility is available in AIIA). |
change in Manasika bhava score in both the group i.e.0th , 15th,30th,45th day.
If facility available in AIIA assessment of EEG and fMRI,in mantra chanting group on 0th and 45th day on as first cum first service (only 10 patient) |
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Target Sample Size
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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" |
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Phase of Trial
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Phase 2/ Phase 3 |
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Date of First Enrollment (India)
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27/01/2026 |
| 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 |
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Estimated Duration of Trial
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Years="1" Months="6" Days="0" |
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Recruitment Status of Trial (Global)
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Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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N/A |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
One of the Kshudraroga Vyanga is distinguished by the presence of Shyavavarna bluish black patches Niruja painless Mandalas on the face. It is among the most prevalent conditions affecting the face. It is comparable to face melanosis one of the hyperpigmented illnesses based on clinical characteristics. In addition to helping with Raktashodhana blood cleansing drugs having Rakta Prasadaka Twak Prasadaka and Varnyakara qualities are useful in the treatment of Vyanga. Melasma is a common skin problem caused by brown to gray brown patches on the face. Most people get it on their cheeks chin nose bridge forehead and above the upper lip. It is more common in women than men. Pregnancy is a common cause of melasma. It also affects women taking oral contraceptives and hormones. The prevalence of melasma is from 1 percent in the general population to 9 to 50 percent in high risk population. Melasma is an acquired hyper melanosis characterized by asymmetric brown coloured irregular reticulated macules on sun exposed areas of the skin especially the face. While skin pigmentation from sun tanning and post hyperpigmentation fades spontaneously after the stimulus cessation in melasma this reduction usually does not occur. Melasma evolves from alterations in several skin layers and cell types to hyper functional melanocytes which produce and transfer mature melanosomes to the whole epidermis Need of the study Vyanga Melasma is a common skin disorder that often leads to significant psychological distress among affected individuals. Conventional treatments for melasma have limited success and may be associated with undesirable side effects. Ayurveda provides holistic approaches for managing Vyanga focusing on both internal and external therapies. There is currently no concrete evidence regarding the role of Manasika bhava psychological factor in the development or management of Vyanga. However Ayurveda classics have described regarding the etiological role of krodha and shoka in the development of vyanga. Therefore assessing the impact of Manasika bhava and exploring integrative therapies that combine Ayurvedic and psychological interventions may offer safer more effective and evidence based solutions for patients.
AIM AND OBJECTIVE AIM To assess the role of Manasika bhava Hetu in the manifestation of vyanga Melasma and to evaluate the clinical efficacy of Vatankura Lepa and Manjishtha churna along with Mantra chikitsa in its management. OBJECTIVES PRIMARY OBJECTIVE To assess the prevalence of Manasika bhavas in the manifestation of Vyanga Melasma. To evaluate the therapeutic Upshayatmaka effect of Vatankura Lepa in combination with Manjishtha churna and add on effect of Mantra Chikitsa on Vyanga Melasma. SECONDARY OBJECTIVES To evaluate the therapeutic effect along with Mantra chikitsa on serum cortisol level and fMRI EEG electroencephalogram if facility available in AIIA. Expected outcome PRIMARY OUTCOME A higher prevalence of Mansika Bhava is present in vyanga Melasma. Change in MASI Melasma Area and Severity Index SCALE after the treatment Improvement and resolution in sign and symptoms of Vyanga Melasma. SECONDARY OUTCOME Change in serum cortisol level alpha MSH IgE level EEG fMRI. Change in Perceived stress scale. |