CTRI Number |
CTRI/2020/03/024036 [Registered on: 18/03/2020] Trial Registered Prospectively |
Last Modified On: |
17/03/2020 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Study of Prachchhana Karma, Maltadya Tail and Dhavadi Kwath in the patient of Alopecia. |
Scientific Title of Study
|
To study the role of Prachchhana Karma followed by Maltadya Taila along with Dhavadi Kwath in the management of Indralupta w.s.r.to Alopecia. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Manjari Chandravanshi |
Designation |
P.G. Scholar |
Affiliation |
Shri narayan prasad awasthi govt ayurvedic college,raipur |
Address |
Shri Narayan prasad awasthi Govt Ayurvedic College, Raipur Chhattisgarh
Raipur CHHATTISGARH 492010 India |
Phone |
8120393532 |
Fax |
|
Email |
manjarikwd308@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Balendra Singh |
Designation |
Reader H O D |
Affiliation |
Shri Narayan prasad awasthi govt ayurvedic college raipur chhattisgarh |
Address |
Shri Narayan prasad awasthi govt ayurvedic college raipur chhattisgarh
Raipur CHHATTISGARH 492010 India |
Phone |
9039180335 |
Fax |
|
Email |
drbalendrasingh@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Satrupa Nirmal |
Designation |
Lecturer |
Affiliation |
Shri Narayan prasad awasthi govt ayurvedic college raipur chhattisgarh |
Address |
Shri Narayan prasad awasthi govtayurvedic college raipur chhattisgarh
Raipur CHHATTISGARH 492010 India |
Phone |
9301088046 |
Fax |
|
Email |
rupa.nirmal1985@gmail.com |
|
Source of Monetary or Material Support
|
Dept. of Shalya tantra Shri Narayan Prasad Awasthi Govt. Ayurved college Raipur C.G. |
|
Primary Sponsor
|
Name |
Dept of Shalya tantra Shri Narayan Prasad Awasthi Govt Ayurved college Raipur CG |
Address |
Shri Narayan Prasad Awasthi Govt. Ayurved college Raipur C.G |
Type of Sponsor |
Other [Shri Narayan Prasad Awasthi Govt. Ayurved college Raipur C.G] |
|
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 |
MANJARI CHANDRAVANSHI |
Shri Khudadad Doongaji Govt. Ayurved Hospital Raipur C. G. |
Opd No- 15 Department of Shalya Tantra, Shri Khudadad Doongaji Govt. Ayurved Hospital Raipur C. G. Raipur CHHATTISGARH |
8120393532
manjarikwd308@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional ethics committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: L63||Alopecia areata, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
- 20 patients will be taken for study. The patients of this group will be managed by Maltadya taila shiroabhayanga along with Dhavadi kwath for shiroprakshalana |
Route of administration- Maltadya Taila- Local application
Dhavadi kwath-Shiroprakshalana (Head bath)
Duration of treatment- Maltadya Taila – Apply daily for 6 weeks.
Dhavadi kwath- Apply at the interval of 3 days for 6 weeks
Follow up - Once in 15 days for 1 month.
|
Comparator Agent |
20 patients will be taken for study. The patients of this group will be managed by Prachchhana karma and Maltadya taila shiroabhayanga along with Dhavadi kwath for shiroprakshalan. |
Route of administration- Maltadya Taila- Local application
Dhavadi kwath-Shiroprakshalana (Head bath)
Duration of treatment- Prakshachhana karma- 6 sittings in a gap of 7 days for 6 weeks.
Maltadya Taila – Apply daily for 6 weeks.
Dhavadi kwath- Apply at the interval of 3 days for 6 weeks
Follow up - Once in 15 days for 1 month.
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
35.00 Year(s) |
Gender |
Male |
Details |
Age group- 18 to 35 years.
Sex- only male patients are included.
Habitat- Both urban and rural area is selected.
Type of patients-
1.Alopecia areata
2.Early stage of androgenic alopecia
3.Alopecia caused by fungal infection and traction.
|
|
ExclusionCriteria |
Details |
Patients having age is less than18 years and above 35 years.
Female patients are excluded.
Patients having history of hair loss due to injury.
Asadhya lakshana has been excluded.
Patients suffering from any severe systemic disease are excluded.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Other |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Regrowth of hair
Improve quality of life
|
6 week
|
|
Secondary Outcome
|
Outcome |
TimePoints |
Incidence of treatment related adverse effects and recurrence rate. |
6 week |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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 1/ Phase 2 |
Date of First Enrollment (India)
|
20/03/2020 |
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
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Hair form an important anatomical structure of the body, derived from ectoderm of skin. Hair is made up of keratin protein. Hair loss is consider the fall of hair from head. In modern science loss of hair known as Alopecia or baldness. There are many types of alopecia depending upon the pattern of hair loss. Two forms of Alopecia- 1. In Scarring alopecia- There area associated fibrosis, a decreased number of follicular openings. 2. In Non-scarring alopecia- Reversible nature hair shafts are gone, but the hair follicles are preserved. Eg. - Androgenic alopecia, alopecia areata, tinea capitis etc. The prevalence of alopecia in India is 58% of the male population age between 30-50 years had AGA (Male androgenic alopecia). In Ayurveda, hair problem described under the broad heading of Kshudra Rogas except Acharya Vagbhata who has mentioned it under Kapal Roga. Alopecia is known as Indralupta or Khalitya or Rujya. Indralupta is loss of hair in form of patches in scalp area. Due to pitta associated with vata reaches Romakupa causes hair fall, later on kapha dosha along with rakta obstructs the Romakupa and restricts their re-growth1. Acharya charak described that due to vitiation of asthi dhatu khalitya occurs as the mala of asthidhatu is keshya (hair). The Ayurveda suggest many preventive and curative measures for Indralupta Shiroabhyanga, Lepa, Rasayana and Nasya are described. Also Shastra karma like Prachchhana and Siravedha has been adopted for the management of Indralupta. Prachchhana helps in draining the vitiated Rakta and plays an important role in Sampraptivighatana of Indralupta. The application of Maltadya taila on the scalp with finger tips leads to increase the local blood circulation. Dhavadi kwath is used for head bath. |